[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-with-preserved-ejection-fraction-hfpef\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-with-preserved-ejection-fraction-hfpef":64},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,35,0,25,[9,48,83,113,139,167,195,223,243,267,294,318,349,385,420,443,463,487,525,552,575,603,624,648,670],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100568255","elevate-hfpef-clinical-study-100568255",false,"NCT06678841","ELEVATE-HFpEF Clinical Study","Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)","ELEVATE-HFpEF","Inclusion Criteria:\n\n1. Age ≥ 40 years\n2. Documented EF ≥50% within the preceding 12 months\n3. HFpEF defined as:\n\n   1. Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR\n   2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:\n\n      * Interstitial \u002F pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure\n      * Elevated NT-proBNP in the last year defined as \\>400 pg\u002Fm for patients with no AF or paroxysmal AF, or \\>900 pg\u002Fml for patients with ≥persistent AF\n      * Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)\n      * Echo criteria defined by ≥2 of:\n\n        * LV wall thickness ≥ 12 mm\n        * LV mass index (BSA indexed LVH): sex at birth male \\>115 g\u002Fm2, sex at birth female \\>95 g\u002Fm2\n        * Relative wall thickness ≥0.42\n        * E\u002Fe' ≥15 in sinus rhythm (or \\> 11 in the setting of atrial fibrillation) OR septal \\\u003C7 cm\u002Fs or lateral e' \\\u003C10cm\u002Fs\n        * Tricuspid regurgitation (TR) velocity \\>2.8 m\u002Fs\n        * Left atrial (LA) enlargement, defined by LA volume index \\>34 ml\u002Fm2\n4. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days\n5. Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible)\n6. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).\n\nExclusion Criteria:\n\n1. Improved or recovered EF (i.e., prior LVEF\\\u003C50%)\n2. Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT))\n3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)\n4. Average heart rate \\\u003C50 bpm or symptomatic bradycardia\n5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit.\n6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and\u002For inotropic drugs.\n7. Severe obesity defined as BMI \\>45.\n8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \\\u003C50 bpm or evidence of ventricular pauses exceeding 6 seconds\n9. Planned AF ablation\n10. Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)\n11. Hypertrophic cardiomyopathies\n12. Uncontrolled hypertension as defined by BP \\>160\u002F100 mmHg on two measurements ≥15 minutes apart\n13. End Stage Renal Disease (CKD 4 or greater)\n14. More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)\n15. Significant primary pulmonary disease on home oxygen\n16. Known contraindication for a pacemaker implant\n17. Advanced co-morbidity with life expectancy \\\u003C 1 year\n18. Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager.\n19. Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).","ALL","40 Years",{"count":21,"type":22},700,"ESTIMATED","INTERVENTIONAL",[25],"NA","ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).",[28],"Heart Failure With Preserved Ejection Fraction (HFpEF)",[30,31,32,33,34],"Heart Failure","Heart Disease","Cardiovascular Disease","Concentric Hypertrophy","Concentric Remodeling","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2025-07-09",{"date":43,"type":22},"2029-02",{"name":45,"class":46},"Medtronic Cardiac Rhythm and Heart Failure","INDUSTRY",46,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100633682","ai-based-echocardiography-for-detection-of-cardiac-amyloidosis-100633682","NCT07529860","AI-based Echocardiography for Detection of Cardiac Amyloidosis","AI-based Echocardiography for Detection of Cardiac Amyloidosis in Patients Undergoing Transthoracic Echocardiography With Left Ventricular Hypertrophy","ORCHESTRA","Inclusion Criteria:\n\n* Patients 18 years old or older\n* Left ventricular hypertrophy defined by a wall thickness of at least 12 mm\n* Echocardiographic red flags of suspected cardiac amyloidosis\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patients with poor echocardiographic acoustic window to allow proper analysis of the data\n* Patients with known cardiac amyloidosis.","18 Years","95 Years",{"count":59,"type":22},200,[25],"Cardiac amyloidosis is characterized by deposition of misfolded protein in the myocardium causing mainly heart failure symptoms with preserved left ventricular ejection fraction. There are also specific clinical (bilateral carpal tunnel syndrome, polyneuropathy, skin bruising, ruptured biceps tendon…), biomarkers (disproportionally elevated NT-proBNP to the degree of heart failure, persistent elevated troponin, proteinuria..), electrocardiographic (reduced voltage of QRS, atrial fibrillation..) and echocardiographic features (concentric left ventricular hypertrophy, dilated atria, reduced global longitudinal strain with typical pattern of apical sparing, diastolic dysfunction…). Early diagnosis of the disease is crucial to identify patients that may benefit from appropriate treatment. Suspected cardiac amyloidosis on echocardiography or on cardiac magnetic resonance needs to prompt the request of serum free-light chain quantification and serum and urine immunofixation as well as single photon emission computed tomography (SPECT) using bone radiotracers. Echocardiography is the imaging technique of first choice to evaluate patients with dyspnea complaints and suspected heart failure as well as other pathologies. Echocardiography is a technique of first choice to evaluate patients with cardiovascular risk factors such as arterial hypertension and diabetes and many of those patients may have echocardiographic features that can be observed in early phases of cardiac amyloidosis. Currently, identification of patients with cardiac amyloidosis with available echocardiographic tools remains challenging. However, novel artificial intelligence (AI)-based algorithms applied to echocardiographic images for analysis may help the cardiologists in the identification of early phase of cardiac amyloidosis. Early diagnosis of cardiac amyloidosis is key to implement effective therapies that have demonstrated to improve survival. Several studies have demonstrated the accuracy of AI-based algorithms applied to echocardiography for the diagnosis of cardiac amyloidosis. The hypothesis of the present prospective study is to evaluate the accuracy of the AI-based algorithm to identify patients with echocardiographic findings suggestive of cardiac ATTR amyloidosis using as ground truth the subsequent analysis with imaging techniques that permit its diagnosis such as 99mTc-pyrophosphate (PYP) SPECT and cardiac magnetic resonance as well as hematologic tests. If needed, histological confirmation on cardiac or extracardiac tissue could be performed, as recommended by recent consensus document from the Heart Failure Association of the European Society of Cardiology.\n\nIn addition, this study will help to answer the true prevalence of ATTR cardiac amyloidosis among patients referred to transthoracic echocardiography that present red flags for ATTR cardiac amyloidosis. The AI-based algorithm is the software Us2.ai which has been used in other populations for this purpose, as previously published.",[63,64,65],"Cardiac Amyloidosis","Heart Failure With Preserved Ejection Fraction (HFPEF)","Left Ventricular Hypertrophy",[67,68,69,70,71],"artifical intelligence","echocardiography","strain","cardiac amyloidosis","left ventricular hypertrophy","NOT_YET_RECRUITING","2026-06-10",{"date":75,"type":39},"2026-06-12",{"date":77,"type":22},"2026-07-01",{"date":79,"type":22},"2028-10",{"name":81,"class":82},"Germans Trias i Pujol Hospital","OTHER",{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":91,"targetDuration":93,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100643241","hfpef-phenotyping-with-echo-clinical-and-biomarkers-100643241","NCT07642921","HFpEF Phenotyping With Echo, Clinical, and Biomarkers","Phenotyping Heart Failure With Preserved Ejection Fraction (HFpEF) Using Echocardiographic, Clinical, and Biomarker Parameters","The EPIC-HFpEF","Inclusion Criteria:\n\n* Patients ≥ 18 years old\n* Signed patient informed consent form (ICF)\n* Diagnosis of chronic (documented HF hospitalization in the last year) or acute decompensated HF shown by signs and symptoms of HF and LVEF \\>50% and, according to guidelines and the universal definition of HF, elevated levels of natriuretic peptides (NT-proBNP ≥300 pg\u002Fml in sinus rhythm or NTproBNP ≥600 pg\u002Fml in atrial fibrillation), at the time of enrolment (10)\n* Echocardiographic evidence of increased estimated LV filling pressures according to current guidelines\n\nExclusion Criteria:\n\n* Planned participation or participation in a clinical trial;\n* Life expectancy \\\u003C 1 year because of non-cardiac causes;\n* History of recent (6 months) infective, or inflammatory, autoimmune or neoplastic diseases.\n* Stage \\>4 CKD (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 15 ml\u002Fmin\u002F1.73m2),\n* Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischemia or newly developed ischemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 3 months;\n* Chronic pulmonary disease requiring home oxygen, oral steroid therapy or hospitalization for exacerbation within 12 months;\n* Congenital heart disease.\n* Primary pulmonary hypertension\n* Moderate-to-severe degenerative (primary) valve disease\n* Cardiomyopathy based on muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), or known pericardial constriction;\n* Implantation of cardioverter defibrillator (ICD) within 3 months\n* Implanted cardiac resynchronization therapy (CRT) and\u002For stable RV pacing.",{"count":92,"type":22},500,"2 Years","OBSERVATIONAL","The EPIC-HFpEF registry is a nationwide Italian study that follows people with a specific type of heart failure called HFpEF. About 500 patients will be enrolled from several specialized hospitals and monitored for up to two years, without changing their usual treatment.\n\nThe goal is to better understand this complex condition by identifying different patient \"types\" based on clinical features, heart imaging, and blood markers. Researchers will also look at how these groups are treated in real life and how their disease progresses over time.\n\nBy doing this, the study aims to improve how doctors classify and manage HFpEF, moving toward more personalized and effective care for patients in the future.",[64],[98,30,99,100,101,102,103],"Phenotyping","Ejection Fraction","Obesity","Diabetes","Chronic Kidney Disease","HFpEF","2026-06-08",{"date":106,"type":39},"2026-06-11",{"date":108,"type":22},"2026-06-02",{"date":110,"type":22},"2029-07-31",{"name":112,"class":82},"University Of Perugia",{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100643837","early-phase-1-hearts-on-fire-targeting-inflammation-in-heart-failure-with-preserved-ejection-fraction-100643837","NCT07634640","Hearts on Fire: Targeting Inflammation in Heart Failure With Preserved Ejection Fraction","Omega-3 Fatty Acids and Myocardial Inflammation in HFpEF: Preliminary Data and Next Steps","Inclusion Criteria:\n\n* HFpEF\n\nExclusion Criteria:\n\n* Renal insufficiency","85 Years",{"count":122,"type":22},70,[124],"EARLY_PHASE1","Subjects undergo a gadolinium-based CMR followed by an iron infusion and then a repeat CMR in 72 hours",[64],[128],"heart failure with preserved ejection fraction","2026-06-04",{"date":131,"type":39},"2026-06-09",{"date":133,"type":39},"2023-11-03",{"date":135,"type":22},"2027-05-31",{"name":137,"class":82},"University of Florida",1,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":152,"conditions":153,"keywords":156,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":138},"100639226","phase-4-tirzepatide-on-atrial-fibrillation-recurrence-after-catheter-ablation-in-patients-with-obesity-and-hfpef-100639226","NCT07630454","Tirzepatide on Atrial Fibrillation Recurrence After Catheter Ablation in Patients With Obesity and HFpEF","Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Patients With Obese and HFpEF: A Randomized Controlled Trial","TEAR-AF-HFpEF","Inclusion Criteria:\n\n* Age 18 to 80 years\n* Symptomatic atrial fibrillation (paroxysmal or persistent of ≤ 5 years duration), undergoing first-time catheter ablation\n* Body weight criteria (aligned with NMPA-approved tirzepatide indication)，meeting at least one of the following:\n\n  * BMI ≥28.0 kg\u002Fm² (obesity threshold per Chinese criteria), OR\n  * BMI ≥24.0 kg\u002Fm² and \\\u003C28.0 kg\u002Fm² (overweight per Chinese criteria) with at least one weight-related comorbidity: hypertension, dyslipidemia, type 2 diabetes mellitus (T2DM), obstructive sleep apnea syndrome (OSAS), or atherosclerotic cardiovascular disease (ASCVD)\n* HFpEF defined by intraprocedural mean left atrial pressure ≥ 15 mmHg at rest\n* Left ventricular ejection fraction ≥ 50% on echocardiography within 30 days prior to enrollment\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Prior use of any GLP-1 receptor agonist or GIP\u002FGLP-1 dual receptor agonist\n* Type 1 diabetes mellitus; or type 2 diabetes with HbA1c \\> 10%\n* Personal history of pancreatitis; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)\n* Severe gastrointestinal disease, including gastroparesis or active inflammatory bowel disease\n* Prior bariatric surgery\n* Moderate or severe valvular heart disease, hypertrophic cardiomyopathy, cardiac amyloidosis, constrictive pericarditis, or restrictive cardiomyopathy\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²)\n* Active malignancy, excluding basal cell carcinoma\n* Acute coronary syndrome, stroke, percutaneous coronary intervention, or cardiac surgery within 30 days prior to enrollment\n* Pregnancy, lactation, or planned pregnancy within 6 months\n* Life expectancy \\\u003C 12 months\n* Concurrent participation in another interventional clinical trial\n* Any condition that, in the investigator's judgment, would interfere with participation","80 Years",{"count":149,"type":22},602,[151],"PHASE4","This multicenter, randomized, open-label, blinded-endpoint trial evaluates whether weekly subcutaneous tirzepatide for 12 months reduces atrial fibrillation (AF) recurrence after catheter ablation in adults with obesity and heart failure with preserved ejection fraction (HFpEF). HFpEF is diagnosed by direct intraprocedural measurement of mean left atrial pressure (mLAP ≥ 15 mmHg at rest) during the ablation procedure, providing a hemodynamically anchored, homogeneous study population free from the diagnostic ambiguities of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and E\u002Fe' in AF patients. Approximately 602 participants will be randomized 1:1 to tirzepatide (titrated to a target of 10 mg\u002Fweek, maximum 15 mg\u002Fweek) plus standard care, or standard care alone. Both groups receive an identical structured lifestyle intervention. The primary endpoint is the first documented AF\u002Fatrial flutter\u002Fatrial tachycardia episode lasting ≥ 30 seconds, occurring between day 91 and day 365 after ablation, adjudicated by an independent blinded clinical endpoint committee.",[154,28,155],"Atrial Fibrillation","Tirzepatide",[154,155,157,100,103],"GIP\u002FGLP-1 receptor agonist","2026-06-03",{"date":160,"type":39},"2026-06-05",{"date":162,"type":22},"2026-08-01",{"date":164,"type":22},"2029-12-01",{"name":166,"class":82},"Yunlong Wang",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":18,"minAge":174,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":138},"100640050","phase-1-fecal-microbiota-transplantation-for-elderly-patients-with-hfpef-a-randomized-controlled-trial-100640050","NCT07628777","Fecal Microbiota Transplantation for Elderly Patients With HFpEF: A Randomized Controlled Trial","Fecal Microbiota Transplantation for Elderly Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial","Inclusion Criteria:\n\n* 1.Aged ≥ 60 years old;\n* 2.Meeting the diagnostic criteria for HFpEF:\n\n  1. Consistent with the epidemiological and demographic characteristics of HFpEF patients;\n  2. Presence of clinical symptoms and\u002For signs of heart failure;\n  3. Cardiac imaging examination indicating LVEF ≥ 50%;\n  4. In sinus rhythm: BNP ≥ 35 pg\u002Fml and\u002For NT-proBNP ≥ 125 pg\u002Fml;In atrial fibrillation: BNP ≥ 105 pg\u002Fml and\u002For NT-proBNP ≥ 365 pg\u002Fml;\n  5. Meet at least one of the following conditions:\n\n     1. LVMI ≥ 115 g\u002Fm² (male) or ≥ 95 g\u002Fm² (female);\n     2. LAVI \\> 34 ml\u002Fm²;\n     3. Relative wall thickness \\> 0.42, or left ventricular free wall thickness \\> 12 mm;\n     4. Septal e' \\\u003C 7 cm\u002Fs, or lateral e' \\\u003C 10 cm\u002Fs, or average E\u002Fe' ≥ 14;\n     5. Tricuspid regurgitation velocity \\> 2.8 m\u002Fs, or pulmonary artery systolic pressure \\> 35 mmHg;\n* 3.NYHA functional class Ⅱ-Ⅲ;\n* 4.Complicated with metabolic diseases such as hypertension, diabetes and obesity;\n* 5.Accompanied by gastrointestinal symptoms;\n* 6.Well-tolerated to current anti-heart failure regimens with stable medication for at least 1 month;\n* 7.Stable heart failure condition without acute exacerbation;\n* 8.Basically normal cognitive function, capable of understanding scale assessment contents;\n* 9.Able to perform daily activities independently;\n* 10.Fully understanding the purpose of this clinical trial, voluntary participation and signing of written informed consent.\n\nExclusion Criteria:\n\n* 1.Symptoms caused by non-cardiac diseases;\n* 2.Patients with any contraindication to Fecal Microbiota Transplantation (FMT):\n\n  1. Patients with severe intestinal barrier damage induced by various causes, such as sepsis, active massive gastrointestinal bleeding, intestinal perforation;\n  2. Patients diagnosed with fulminant colitis or toxic megacolon;\n  3. Patients unable to tolerate enteral nutrition meeting 50% of calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal hemorrhage, high-output intestinal fistula and other conditions;\n  4. Patients with congenital or acquired immunodeficiency diseases;\n  5. Patients receiving high-risk immunosuppressive or cytotoxic drugs recently, such as rituximab, doxorubicin, or moderate-to-high dose steroids (prednisone ≥ 20 mg\u002Fd) administered continuously for more than 4 weeks;\n  6. Severely immunosuppressed patients with neutrophil count \\\u003C 1500\u002Fmm³;\n* 3.History of myocardial infarction, coronary artery bypass grafting, or any event that may reduce LVEF within 6 months before enrollment (unless LVEF ≥ 50% was confirmed);\n* 4.Received valve replacement surgery within 6 months before enrollment;\n* 5.Poorly controlled blood pressure (SBP ≥ 180 mmHg or DBP ≥ 100 mmHg);\n* 6.Current acute decompensated heart failure requiring intervention;\n* 7.Resting heart rate \\> 120 beats per minute, or complicated with malignant arrhythmia;\n* 8.Significant coronary artery disease requiring PCI revascularization;\n* 9.Severe renal insufficiency (serum creatinine \\> 442 μmol\u002FL) or patients on dialysis;\n* 10.Pre-existing gastrointestinal diseases, including ulcerative colitis, Crohn's disease, irritable bowel syndrome, chronic diarrhea;\n* 11.Current malignant tumors requiring anti-tumor treatment;\n* 12.Complicated with acute diseases or acute exacerbation of chronic diseases at present;\n* 13.Participation in other interventional clinical trials or oral intake of probiotic preparations within the past 3 months.","60 Years",{"count":176,"type":22},50,[178,179],"PHASE1","PHASE2","This is a single-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) in elderly patients with heart failure with preserved ejection fraction (HFpEF).\n\nHFpEF is a common type of heart failure in older adults, often associated with poor quality of life and frequent hospitalizations. Recent research suggests that changes in gut bacteria may contribute to the progression of HFpEF. FMT aims to restore a healthy gut microbiome, which may improve heart function and reduce symptoms.\n\nParticipants will be randomly assigned to receive either FMT or a placebo treatment. The primary goal is to compare changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score between the two groups at 20 weeks. Secondary goals include assessing improvements in exercise capacity (6-minute walk test), NYHA functional class, and safety outcomes.\n\nThe study will enroll 50 elderly patients (aged ≥60 years) with confirmed HFpEF. All participants will receive standard medical care for HFpEF throughout the study. This trial is sponsored by The First Affiliated Hospital of Air Force Medical University and conducted in accordance with ethical standards.",[64,182],"Chronic Heart Failure",[184,103,185,186],"Heart Failure with Preserved Ejection Fraction","Fecal Microbiota Transplantation","FMT","2026-06-01",{"date":160,"type":39},{"date":190,"type":22},"2026-06",{"date":192,"type":22},"2028-12-31",{"name":194,"class":82},"The First Affiliated Hospital of Air Force Medicial University",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":210,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100639489","clinical-feasibility-of-cardiac-neuromodulation-therapy-for-heart-failure-with-preserved-ejection-fraction-100639489","NCT07598760","Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction","Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Clinical indication for dual-chamber pacemaker implantation or replacement\n* Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction ≥50%\n* History of hypertension\n* NYHA functional class II or III\n* On stable guideline-directed medical therapy\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* NYHA class IV heart failure\n* Permanent or persistent atrial fibrillation\n* Recent acute decompensated heart failure\n* Significant valvular heart disease requiring intervention\n* Severe comorbid conditions that, in the investigator's judgment, would make study participation unsafe\n* Pregnant or breastfeeding individuals",{"count":203,"type":22},20,[25],"This is an open-label pilot study to evaluate the feasibility of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who require dual-chamber pacemaker implantation or replacement. The study will assess blood pressure and heart function at rest and during exercise, with and without CNT, for up to 12 months. Participants will receive the Moderato Plus device and complete scheduled follow-up visits. After study completion, CNT therapy will be discontinued and participants will return to standard medical care.",[207,208,209],"Hypertension (HTN)","Heart Failure With Preserved Ejection Fraction (HFpEF","Hypertension, Systolic",[211,103,212],"CNT","Hypertension","2026-05-14",{"date":215,"type":39},"2026-05-20",{"date":217,"type":22},"2026-05-30",{"date":219,"type":22},"2028-11-30",{"name":221,"class":46},"BackBeat Medical Inc",2,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":4},"100636432","changes-in-intramyocardial-fat-assessed-by-cardiac-ct-before-and-after-bariatric-surgery-and-their-relationship-with-cardiac-diastolic-function-100636432","NCT07565610","Changes in Intramyocardial Fat Assessed by Cardiac CT Before and After Bariatric Surgery and Their Relationship With Cardiac Diastolic Function","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Scheduled to undergo bariatric surgery for standard clinical indications\n* Left ventricular ejection fraction (LVEF) ≥50%\n* Able to undergo cardiac computed tomography (CT)\n\nExclusion Criteria:\n\n* Left ventricular ejection fraction (LVEF) \\\u003C50%\n* Known cardiomyopathies, including sarcoidosis, amyloidosis, or myocarditis\n* Significant valvular heart disease\n* Contraindication to cardiac CT (e.g., severe renal dysfunction, contrast allergy)\n* Presence of intracardiac or cardiac-related foreign material that may interfere with imaging (e.g., prosthetic valves, pacemakers, prior transcatheter devices)",{"count":230,"type":22},150,"The goal of this observational study is to learn if weight loss surgery can lower fat inside the heart muscle and improve how the heart relaxes in adults with obesity.\n\nThe main questions it aims to answer are:\n\nDoes fat inside the heart muscle decrease after weight loss surgery? Does heart relaxation (diastolic function) improve after surgery? Are changes in heart fat linked to changes in weight, body fat, and blood markers?\n\nParticipants who are already planning to have weight loss surgery will take part in this study.\n\nParticipants will:\n\nHave a heart CT scan to measure fat in the heart muscle before surgery and about 6 months after surgery Have an ultrasound of the heart (echocardiogram) to check how the heart fills and relaxes Have body composition testing to measure fat and muscle Have blood tests, including routine tests and additional markers related to heart function and metabolism\n\nResearchers will compare each participant's results before and after surgery to see if heart fat decreases and if heart function and blood markers improve.",[100,233,64],"Diastolic Dysfunction","2026-04-29",{"date":236,"type":39},"2026-05-04",{"date":238,"type":22},"2026-05",{"date":240,"type":22},"2028-05",{"name":242,"class":82},"Itshak Amsalem",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":138},"100575142","the-role-of-epicardial-adiposity-in-heart-failure-with-preserved-ejection-fraction-100575142","NCT06768437","The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction","EAT HFpEF","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Aged ≥18 years old\n* Diagnosed with HFpEF by an experienced cardiologist or signs and symptoms of heart failure with a HFA-PEFF score ≥5\n* Able to understand written English\n\nExclusion Criteria:\n\n* LV ejection fraction \\\u003C45%\n* Recovered ejection fraction (previous ejection fraction \\\u003C40%) unless reduced ejection fraction was in context of tachycardia induced cardiomyopathy (eg atrial fibrillation\u002Fatrial flutter)\n* Severe primary valvular heart disease\n* HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy\u002Fpericardial disease or congenital heart disease\n* Known heritable, idiopathic or drug-induced pulmonary arterial hypertension\n* Absolute contraindications to cardiac CT or MRI including estimated glomerular filtration rate (eGFR) ≤30ml\u002Fmin\u002F1.73m2. Patients with MRI-compatible devices are be excluded.\n* Women who are pregnant",{"count":251,"type":22},130,"In this study the investigators are aiming to recruit 130 patients with heart failure with preserved ejection fraction who are obese and non-obese to undergo CT and MRI scans, as well as some other investigations including blood tests, to help investigate if having more fat around the heart leads to worse heart function in this condition. This may lead to the development of new treatments aimed at lowering fat levels around the heart and in the rest of the body, specifically to treat HFpEF.",[64],[255,256,257,258],"Heart failure","Heart failure with preserved ejection fraction","Epicardial adipose tissue","Adiposity",{"date":260,"type":39},"2026-04-30",{"date":262,"type":39},"2025-02-12",{"date":264,"type":22},"2037-08",{"name":266,"class":82},"University of Leicester",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":138},"100636034","phase-2-coronary-artery-stents-in-heart-failure-with-preserved-ejection-fraction-100636034","NCT07560436","Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction","REvascularisation for Heart Failure With PReserved Ejection Fraction and Ischaemia: EValuation of Efficacy and Mechanistic Description","REPRIEVED","Inclusion Criteria:\n\n1\\. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, defined as:\n\n1. Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and\n2. Left ventricular ejection fraction ≥ 50% and\n3. NT-pro-BNP \\> 125 pg\u002Fml in sinus rhythm or \\> 365 pg\u002Fml in atrial fibrillation and\n4. One or more of the following objective signs of left ventricular diastolic dysfunction:\n\ni. Invasively measured left ventricular end diastolic pressure ≥ 15 mmHg at rest or ≥ 25 mmHg on exercise (directly measured or estimated via pulmonary capillary wedge pressure) ii. Estimated pulmonary artery systolic pressure \\> 35mmHg or tricuspid regurgitation velocity \\> 2.8 m\u002Fs on echocardiography iii. Left atrial volume index \\> 34ml\u002Fm2 in patient in sinus rhythm or left atrial volume index \\> 40ml\u002Fm2 in atrial fibrillation iv. Relative left ventricular wall thickness \\> 0.42 v. Left ventricular mass index ≥ 95 g\u002Fm2 in females or ≥ 115 g\u002Fm2 in males vi. Mitral E\u002FE' ratio \\> 9\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. People without capacity to provide informed consent\n3. PCI contraindicated or not feasible on coronary angiography or screening CTCA\n4. Contraindication to clopidogrel\u002Fdual antiplatelet therapy\n5. Recent acute myocardial infarction or coronary revascularisation (within 90 days)\n6. Enrolment in another interventional study which may affect study outcomes\n7. Severe chronic obstructive pulmonary disease (GOLD stage ≥3)\n8. Haemoglobin \\\u003C=80 g\u002FL\n9. Other cardiac diagnosis as a cause for HFpEF (hypertrophic cardiomyopathy, untreated severe left sided valvular disease, cardiac amyloidosis)",{"count":276,"type":22},350,[179],"HFpEF (heart failure with preserved ejection fraction) is a condition in which the heart muscle becomes stiff and can't pump blood properly. People living with HFpEF also often have coronary artery disease, where the blood vessels that supply the heart are narrowed or blocked.\n\nIt is not yet know whether opening these arteries with stents improves symptoms or quality of life with HFpEF. REPRIEVED is a randomised clinical trial that aims to find out if heart stents can improve quality of life for people living with heart failure with preserved ejection fraction (HFpEF) and coronary artery disease.\n\nResearchers will compare two groups of people; those who have a stent procedure to those who have a placebo procedure. The placebo procedure feels the same as a stent procedure but does not include a stent.\n\n350 people with HFpEF and coronary artery disease will be asked to take part. Participants will be monitored over a period of 6 months to see if and how quality of life changes.\n\nBefore the procedure, participants will be asked to complete a short health questionnaire, have a blood test, undergo an electrocardiogram (heart tracing) and scans of their heart.\n\nOn the day of the procedure, the participant will come to the hospital for an angiogram and will be randomly allocated to have either treatment with a stent or the placebo procedure without a stent. Participants will not know whether they have received heart stents. This helps researchers know that any improvements in their quality of life are not just related to how they feel about the stenting treatment.\n\nParticipants will then be contacted by a member of the research team at 3 months and 6 months after their procedure.\n\nAt 3 months, participants will complete a short health questionnaire either by phone or during a hospital visit.\n\nAt 6 months, participants will attend the hospital to complete a short health questionnaire, have blood tests, a scan of the heart (echocardiogram) and an electrocardiogram (heart tracing) to measure any changes in the heart.\n\nParticipants will be told whether they received the stent procedure or the placebo procedure.",[64,280],"Coronary Artery Disease",[103,256,273,282,283,284],"REPRIEVED trial","Placebo PCI","CAD","2026-04-27",{"date":287,"type":39},"2026-05-01",{"date":289,"type":39},"2026-03-23",{"date":291,"type":22},"2029-08",{"name":293,"class":82},"King's College London",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":18,"minAge":300,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100609817","phase-1-a-safety-tolerability-and-biomarker-trial-of-vs-041-in-participants-with-heart-failure-with-preserved-ejection-fraction-hfpef-100609817","NCT07219511","A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)","Inclusion Criteria:\n\nParticipants must meet all inclusion criteria to be eligible for trial participation.\n\n1. Males or females ≥ 50 years of age at the time of signing the informed consent.\n2. Diagnosis of HFpEF as defined by European Society of Cardiology or American College of Cardiology\u002FAmerican Heart Association criteria\n3. NYHA Functional Class II or III\n4. LVEF ≥ 50% demonstrated by echocardiography (ECHO) performed at Screening with evidence of heart failure\n5. Elevated NT-proBNP at Screening\n6. NordicPRO-C6™ ≥ 11 ng\u002FmL at Screening.\n7. Stable dose of all concomitant HF medications for at least 4 weeks prior to Screening.\n8. Body weight of at least 110 lbs (50 kg) and body mass index (BMI) within the range ≥ 18 to \\\u003C 45 kg\u002Fm2.\n9. Males must agree to the contraception requirements and females must be of non-childbearing potential\n10. Able to understand and willing to sign a written informed consent form (ICF).\n11. Willing and able to comply with trial procedures and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n1. Female trial participant who is pregnant or breastfeeding.\n2. Known hypersensitivity to VS-041.\n3. Cardiovascular disease other than HFpEF\n4. Active intercurrent illness such as acute bacterial or viral infection.\n5. History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation.\n6. Active chronic viral infection such as Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) at Screening.\n7. Acute decompensated HF within 30 days of Screening\n8. Lung disease within 12 months prior to Screening\n9. History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.\n10. History of any other condition including psychiatric disorders that, in the opinion of the PI, may preclude the participant from following and completing the protocol.\n11. Have participated within the last 6 months in a clinical study involving an investigational product.\n12. Any other reason which, in the opinion of the PI, would prevent the participant from participating in the trial.","50 Years",{"count":302,"type":22},42,[178],"A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)",[306,64],"Heart",[184,103],"2026-04-07",{"date":310,"type":39},"2026-04-09",{"date":312,"type":39},"2025-11-04",{"date":314,"type":22},"2026-07",{"name":316,"class":46},"Vasa Therapeutics",21,{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":174,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":335,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":138},"100617911","preactive-preconditioning-exercise-intervention-to-improve-symptoms-and-quality-of-life-in-comorbid-atrial-fibrillation-and-hfpef-100617911","NCT07324772","PREACTIVE: Preconditioning Exercise Intervention to Improve Symptoms and Quality of Life in Comorbid Atrial Fibrillation and HFpEF","PREACTIVE: Preconditioning With REsistance and AerobiC Training to ImproVe Exercise Intolerance and Quality of Life in Comorbid Atrial Fibrillation and HFpEF","PREACTIVE","Inclusion Criteria:\n\nAll participants will be age 60 and older, have a primary diagnosis of AF and HFpEF, based on electronic health record review. Patients with persistent AF or Paroxysmal AF are eligible. HFpEF will be defined in accordance to the 2022 AHA\u002FACC\u002FHFSA Guideline using a clinical composite score, the H2FPEF score, in conjunction with diagnostic criteria below:\n\n* Ejection fraction ≥ 50%\n* E\u002Fe' ≥15 by Doppler Echocardiography\n* High H2FpEF score (≥5)\n* Must be in stable medical condition and able to begin an exercise program\n\nExclusion Criteria:\n\n* Valvular heart disease as the primary etiology of heart failure (i.e., severe aortic stenosis or mitral regurgitation),\n* New York Heart Association Stage IV\n* Recent stroke (\\\u003C1 year)\n* Evidence or History of Cardiac amyloidosis\n* Patients with persistent AF and poor rate control (HR \\> 110 at rest)\n* Significant change in cardiac medication or Heart Failure symptoms \\\u003C 2 weeks\n* Unstable or severe angina not controlled during daily activity by pharmacological therapy or at \\\u003C4 METS activity\n* Uncontrolled hypertension (defined as systolic blood pressure \\>200 mm Hg and\u002For diastolic blood pressure\\>110 mm Hg) with medications\n* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions\n* Hospitalization or urgent care visit \\\u003C 4 weeks\n* Oxygen dependent Chronic Obstructive Pulmonary Disease (COPD)\n* Significant anemia (\\\u003C10 g\u002FdL Hgb)\n* End stage renal replacement therapy associated with the need for dialysis\n* Active treatment for cancer defined as current radiation, chemotherapy, immunotherapy, or cancer recurrence within past 5 years\n* Hospice care and indication of life expectancy less than 2 years\n* Complete dependence confinement to a Wheelchair confinement or requiring a visual impairment or Orthopedic or severe musculoskeletal conditions that would prohibit resistance training or aerobic exercise.\n* Physician diagnosed Alzheimer's disease or Dementia or bipolar or psychotic disorder; Montreal Cognitive Assessment (MoCA) is ≤ 18 (based on participant screening)\n* High levels of physical functioning based the composite short physical performance battery score of ≥10 (out of 12)\n* Planned major surgery, coronary or leg revascularization during the next six months\n* Participation in a supervised exercise program or already engaging in regular exercise\n* Plans to transfer care outside of NU within the study period\n* Unable to consent or commit to requires study procedures\n* Non-English speaking","99 Years",{"count":328,"type":22},30,[25],"Atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) are very common conditions that often occur together and result in worsening symptoms and reduced quality of life (QoL). Limitations being able to participate in activities of daily living is a primary complaint for AF-HFpEF patients, yet effective strategies to address this issue remain limited. While exercise interventions targeting aerobic training (AT) are recommended for patients with AF and HFpEF, unique challenges exist in this patient population who tend to be older. Specifically, many older patients with AF and HFpEF have muscle weakness, sarcopenia and frailty, that can make aerobic-focused exercise difficult and less tolerable. This study proposes that starting with progressive resistance training (PRT) before aerobic exercise may overcome these issues by improving muscle strength, making AT more manageable, and leading to better health outcomes. The goal of this study is to assess whether a sequential exercise program, named 'PREACTIVE' improves how people feel, decrease the amount of symptoms, and their ability to participate in exercise and activities.\n\nThis study will specifically test a sequenced exercise approach of resistance training followed by aerobic exercise to improve symptoms, and quality of life in AF-HFpEF.",[332,333,334,64],"Atrial Fibrillation (AF)","Atrial Fibrillation (Paroxysmal)","Persistent Atrial Fibrillation",[336,337,338,339],"exercise","exercise capacity","symptom severity","quality of life","2026-04-06",{"date":342,"type":39},"2026-04-08",{"date":344,"type":22},"2026-04-13",{"date":346,"type":22},"2027-05",{"name":348,"class":82},"Northwestern University",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":360,"conditions":361,"keywords":364,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":138},"100607172","determination-of-the-prevalence-of-unrecognized-heart-failure-among-patients-at-risk-in-urban-areas-across-germany-using-cmr-100607172","NCT07185100","Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR","A Prospective, Cross-sectional, Nationwide Community-based Observational Study to Determine the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR","WE-CARE-HF-CMR","Inclusion Criteria:\n\nAsymptomatic subjects with:\n\n* chronic diabetes mellitus (known\u002Fdiagnosed and\u002For antidiabetic medication and\u002For elevated HbA1C) and\u002For\n* renal impairment (known\u002Fdiagnosed CKD and\u002For in laboratory CKD III° or higher) and\u002For\n* Hypertension (known\u002Fdiagnosed and\u002For antihypertensive medication\u002Ftreatment) and\u002For\n* Hypercholesterolaemia (known\u002Fdiagnosed and\u002For antilipid medication\u002Ftreatment) and\u002For\n* Obesity (known\u002Fdiagnosed and\u002For BMI \\> 30 (kg\u002Fm²)) and\u002For\n* Smoker (known\u002Fdiagnosed and\u002For current\u002Fprevious and\u002For medication\u002Ftreatment)\n* Age 40-69 years\n* female or male or diverse sex\n* Ability to provide informed consent\n* Provision of Informed Consent\n\nExclusion Criteria:\n\n* Inability to provide written informed consent\n* Diagnosed heart failure or previously detected reduced ejection fraction\n* General MRI exclusion criteria (pacemaker, defibrillator, intracranial aneurysm clips, metallic foreign bodies in the eyes)\n* Any MRI exclusion criteria not listed here, as determined by the MRI laboratory performing the procedure\n* Haemodynamically unstable participants (heart rate \\\u003C 45\u002Fmin, systolic blood pressure \\\u003C 90 mmHg)\n* Claustrophobia\n* Sensorineural hearing loss of 30 dB or more and tinnitus\n* Acute mental disorders requiring therapy\n* In the presence of pregnancy","69 Years",{"count":359,"type":22},600,"Heart failure (HF) in patients at risk is often overlooked, and when detected, there is a lack of early and effective preventive interventions. The WE-CARE-HF-CMR study, conducted in large cities\u002Fmetropol areas in Germany ( \\> 1.000.000 inhabitants), aims to close this gap by evaluating the feasibility of a mobile, telemedicinemonitored HF-screening approach combining cardiac magnetic resonance imaging (CMR), quality of life assessment and laboratory tests as key elements in asymptomatic patients at risk. WE-CARE-HF-CMR will provide a proposal for a comprehensive, contemporary screening approach for patients at risk to develop HF tailored to the needs of the target population. This will provide important new information on the prevalence of asymptomatic HF in at-risk patients in urban versus rural areas.\n\nThe results of the study will be compared with the results from the \"HERZCheck'' trial, which provides data from approximately 4,500 participants in rural areas in Germany and has already been completed (NCT05122793).",[64,362,363],"Renal Dysfunction","Stage B Heart Failure",[365,255,103,366,367,368,369,370,371,372,233,373,374,375],"Prevention","Asymptomatic","Cardiology","Urban area","Germany","CMR","Cardiac Magnetic Resonance","HFrEF","Strain","mobile","GLS","2026-03-26",{"date":378,"type":39},"2026-04-01",{"date":380,"type":39},"2025-09-13",{"date":382,"type":22},"2036-12-31",{"name":384,"class":82},"German Heart Institute",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":392,"minAge":56,"maxAge":120,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":401,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":415,"leadSponsor":417,"locationsCount":419},"100615662","phase-4-pharmacological-optimization-in-prevention-in-heart-failure-a-sex-gap-100615662","NCT07295522","Pharmacological Optimization in Prevention in Heart Failure: A Sex-gap?","PopS-HF","Inclusion Criteria:\n\n1. Female patients \\>18 \\\u003C85 years.\n2. Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and\u002For symptoms of heart failure such as edema and\u002For positive rales on auscultation.\n3. All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.\n4. All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq\u002FL (mmol\u002FL).\n5. Biomarker criteria for persistent congestion:\n\n   5.1. At Screening, NT-proBNP \\>1,800 pg\u002FmL (2,350 pg\u002FmL in case of atrial fibrillation) 5.2. At the time of Randomization (1-2 days prior to discharge), NT-proBNP \\>1,000 pg\u002FmL (1,300 pg\u002FmL in case of Atrial Fibrillation) to ensure the persistence of congestion and the acuity of the index episode).\n6. At 1 week prior to admission, at Screening, and at Visit 2 6.1. If EF\\\u003C50% (ie HFrEF or HFmrEF) either \\\u003C½ the optimal dose of ACEi\u002FARB\u002FARNi and MRA and BB or no SGLT2i (see Table) must have been prescribed 6.2. If EF\\>50% (ie HFpEF): \\\u003C½ the optimal dose of MRA (see Table) or no SGLT2i.\n7. Written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Male patients\n2. Age \\\u003C 18 or \\> 85 years.\n3. Mechanical ventilation (not including CPAP\u002FBIPAP) in the 24 hours prior to Screening.\n4. Significant pulmonary disease contributing substantially to the patients' dyspnoea such as FEV1 \\\u003C1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism.\n5. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening or during the index event.\n6. Index Event (admission for Acute Heart Failure) triggered primarily by a correctable aetiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation\u002Fflutter with sustained ventricular response \\>130 beats per minute, or bradycardia with sustained ventricular arrhythmia \\\u003C45 beats per minute), infection, severe anaemia, acute coronary syndrome, pulmonary embolism, exacerbation of Chronic Obstructive Pulmonary Disease (COPD), planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion.\n7. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.\n8. History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.\n9. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.\n10. Presence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion\n11. Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated WBC or need for intravenous antibiotics.\n12. Stroke or Transient Ischemic Attack (TIA) within the 3 months prior to Screening.\n13. Primary liver disease considered to be life threatening.\n14. Renal disease or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 (as estimated by the simplified MDRD formula) at Screening or history of dialysis.\n15. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \\\u003C 6 months.\n16. Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening or 5 half-lives of the study drug, whichever is longer.\n17. Discharge for the AHF hospitalization anticipated to be \\>14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and at 1-2 days prior to anticipated discharge.\n18. Inability to comply with all study requirements, due to major co-morbidities, social or financial issues or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and\u002For comply with the protocol instructions or follow-up procedures.\n19. Pregnant or nursing (lactating) women.\n20. Hypersensitivity to the active substance or to any of the excipients as indicated in Summary of Product Characteristics of Investigational Medicinal Product (IMPs).\n21. Angioedema.\n22. Severe heart failure (NYHA class IV).","FEMALE",{"count":394,"type":22},368,[151],"The goal of this clinical trial is to learn whether a rapid and intensive optimization of heart failure medications in women can improve outcomes after hospitalization for heart failure. It will also investigate the safety and the tolerance of these treatments when given at full guideline-recommended doses.\n\nThe main questions it aims to answer are:\n\n1. Does intensive medication optimization reduce death or hospital readmissions for heart failure within one year?\n2. Do women benefit as much as men from intensive and full-dose heart failure therapy?\n3. Is this treatment protocol safe and feasible also in women?\n\nResearchers will compare two groups of women hospitalized for heart failure:\n\n* High-intensity care: starting and increasing all recommended heart-failure medications as quickly as possible and monitoring patients closely during the first weeks after discharge.\n* Usual care: medications are started and adjusted gradually, according to the judgment of the treating cardiologist and the patient's usual care team.\n\nThe study will follow participants for 12 months to see whether the high-intensity strategy reduces death, hospital readmission for heart failure, or worsening symptoms. It will also evaluate side effects, medication tolerance, and quality of life.\n\nParticipants will be randomly assigned to one of the two groups, attend regular follow-up visits for one year, complete a short quality-of-life questionnaire (EQ-5D).\n\nThis study will include about 360 women from 13 hospitals in Italy. It is sponsored by IRCCS Policlinico San Donato and funded by the Italian Medicines Agency (AIFA).",[30,398,399,64,400],"Acute Heart Failure","Heart Failure With Reduced Ejection Fraction (HFrEF)","Heart Failure With Mildly Reduced Ejection Fraction",[402,403,404,405,406,407,408,409,410],"heart failure","women","GDMT","Pharmacological Optimization","phase IV","High intensity up-titration","Secondary prevention","Sex differences","Real world data","2026-03-25",{"date":413,"type":39},"2026-03-30",{"date":342,"type":22},{"date":416,"type":22},"2028-06-08",{"name":418,"class":82},"IRCCS Policlinico S. Donato",13,{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":428,"enrollmentInfo":429,"targetDuration":431,"studyType":94,"phases":4,"briefSummary":432,"conditions":433,"keywords":434,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":439,"leadSponsor":441,"locationsCount":138},"100630893","capture-hfpef-national-study-of-identification-and-phenotyping-of-heart-failure-with-preserved-ejection-fraction-100630893","NCT07493590","CAPTURE-HFpEF: National Study of Identification and Phenotyping of Heart Failure With Preserved Ejection Fraction","CAPTURE-HFpEF (Cardiovascular Assessment and Phenotyping for Timely Understanding and Recognition of Evolving Heart Failure With Preserved Ejection Fraction)","CAPTURE-HFpEF","Inclusion Criteria:\n\n* Patients \\>60 years with ≥1 risk factor, OR\n* Patients \\>50 years with ≥2 risk factors\n* Hypertension\n* Type 1 or 2 diabetes\n* Chronic kidney disease (eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²)\n* Previous cardiotoxic drug exposure\n* atrial fibrillation\n* Ischemic heart disease\n* Previous heart valve surgery\u002Fintervention\n* Body mass index \\>30 kg\u002Fm² (self-reported)\n* Use of ≥40 mg furosemide\n* Obstructive sleep apnea\n* Non-alcoholic fatty liver disease\n\nExclusion Criteria:\n\n* Cancer \\\u003C1 year\n* Dialysis\n* COPD and O2\n* Nursing home\n* Age \\>90 years\n* Dementia\n* Known dilated cardiomyopathy\n* Prior organ-transplantation\n* Amyloidosis","90 Years",{"count":430,"type":22},30000,"10 Years","The goal of this observational study is to improve early detection, characterization, and understanding of heart failure with preserved ejection fraction (HFpEF) in adults at risk of or diagnosed with HFpEF, including men and women across Danish regions.\n\nThe main questions to answer are:\n\nCan systematic cardiovascular screening and deep phenotyping improve early identification and classification of HFpEF?\n\nWhich clinical, imaging, biomarker, and metabolic characteristics define subtypes (phenotypes) of HFpEF and predict disease progression and outcomes?\n\nResearchers will compare participants with HFpEF, participants at risk of HFpEF, and relevant control groups to see if differences in biomarkers, imaging findings, and clinical characteristics can identify early disease stages and distinct HFpEF phenotypes.\n\nParticipants identified with HFpEF will:\n\n* Undergo detailed cardiovascular examinations (e.g., echocardiography, CT and other imaging examinations, RHC, CPET)\n* Provide blood and tissue samples for biomarker and metabolic analyses\n* Complete clinical assessments and questionnaires\n* Have relevant health data collected from national health registries\n* Attend follow-up assessments to monitor disease progression",[64],[255,435,436,32,182],"Heart Failure with Preserved Ejection Fraction (HFpEF)","Cardiovascular Mortality",{"date":411,"type":39},{"date":378,"type":22},{"date":440,"type":22},"2035-04-01",{"name":442,"class":82},"Herlev and Gentofte Hospital",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":222},"100585672","the-use-of-advanced-imaging-in-hfpef-100585672","NCT06905405","The Use of Advanced Imaging in HFpEF","Assessing the Ability to Improve the Diagnosis of Heart Failure With Preserved Ejection Fraction Using Advanced Imaging Techniques","Inclusion Criteria:\n\n* Male or female \\> 18yrs of age.\n* Symptoms of dysponea on exertion.\n* NTproBNP \\>400 ng\u002FL in sinus rhythm (SR).\n* Baseline TTE demonstrating a dilated LA (LA\\>34 ml\u002Fm2), but that otherwise does not meet the current criteria for the diagnosis of HFpEF or HFrEF (preserved LV systolic function, Normal E\u002Fe', no evidence of LVH, Estimated PAP \\\u003C 35mmhg).\n\nExclusion Criteria:\n\n* Inability to give informed consent. History of HFrEF\n* contraindications to SGLT2 inhibitor (a history of type 1 diabetes mellitus, ketoacidosis, allergy to SGLT2 inhibitors, planned or current use of SGLT2 inhibitors or active genital infection).\n* Atrial Fibrillation.\n* Current history of anginal chest pain",{"count":451,"type":22},40,"Heart failure with preserved ejection fraction (HFpEF) causes symptoms of breathlessness and leg swelling. It is associated with significant number of hospital admissions and could lead to the patient's death. In HFpEF, the pumping function of the heart is normal but the heart is too stiff to fill properly. The first line investigation is an ultrasound of the heart (echocardiography). A number of parameters are assessed that indicate stiffness within the heart or raised pressures within the heart. However, most of these parameters lack sensitivity which can make HFpEF difficult to diagnose. The best test is to invasively measure the pressures in the heart at rest and with exercise in a procedure called heart catheterisation. However, this is invasive and not readily available. As a result, HFpEF is significantly under diagnosed meaning many patients do not get access to disease specific treatment that may improve symptoms and quality of life. There are a number of new imaging techniques that may help us to better identify HFpEF . However, it is not currently known how to best apply them in clinical practice.\n\nIn this study, the investigators will recruit patients presenting to the HF clinic at Sheffield Teaching Hospitals who have symptoms of HFpEF but whose diagnosis remains unclear after initial assessment. The impact of their symptoms will be assessed with the use of a quality of life (QoL) questionnaires and a six-minute walk test (6MWT). They will undergo advanced imaging with a specialist echocardiogram and a cardiac MRI scan. If they are found to have features of HFpEF, they will be started on disease specific treatment. All patients will be followed up after six months to see if they have any symptomatic or functional improvement. They will also undergo repeat imaging to see if there has been any change in the imaging parameters.",[64],"2026-03-16",{"date":456,"type":39},"2026-03-18",{"date":458,"type":39},"2025-08-05",{"date":460,"type":22},"2027-09-30",{"name":462,"class":82},"Sheffield Teaching Hospitals NHS Foundation Trust",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":472,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":203},"100407977","endovascular-ablation-of-the-right-greater-splanchnic-nerve-in-subjects-having-hfpef-100407977","NCT04592445","Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF","Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction: Randomized Controlled Feasibility Trial - The Rebalance HF Study","Rebalance-HF","Inclusion Criteria\n\n1. Chronic heart failure, defined as:\n\n   1. Symptoms of HF requiring current (intermittent or continuous) treatment with diuretics for \\>30 days, AND\n   2. NYHA class II with a history of \\>NYHA class II in the past year, NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening or signs of HF (any rales post cough, chest x-ray demonstrating pulmonary congestion), AND\n   3. At least one of the following:\n\n   i. ≥1 HF hospital admission (with HF as the primary diagnosis) including treatment with intravenous (IV) diuretics or urgent unplanned treatment with IV diuretics in healthcare facility within past 12 months, OR ii. NT-proBNP \\>300 pg\u002Fml in normal sinus rhythm (\\>450 pg\u002Fml in atrial fibrillation or flutter) within the past 6 months; BNP \\>100 pg\u002Fml in normal sinus rhythm (\\>300 pg\u002Fml in atrial fibrillation or flutter) within the past 6 months, OR iii. Right heart catheterization (RHC) with PCWP ≥ with PCWP ≥18 mmHg at rest or 25 mmHg during exercise at the time of the screening RHC.\n2. Ongoing stable GDMT HF management (unless unable to tolerate GDMT) and management of potential comorbidities according to the 2022 ACCF\u002FAHA Guideline for the Management of Heart Failure (Class 1 and 2a recommendations), with no significant changes \\[≥100% increase or ≥50% decrease\\] for a minimum of 1 month (30 days) prior to screening, that is expected to be maintained without change for at least 6 months. Participants cannot have started a glucagon-like peptide (GLP)-1 or gastric inhibitory peptide (GIP) agonist within the last 6 months or plan to start a GLP-1 or GIP agonist within the ensuing 6 months after enrollment.\n3. LVEF ≥50% (site-determined by transthoracic echocardiography) within the past 6 months.\n4. Age ≥40 years.\n5. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.\n\nExclusion Criteria:\n\n1. MI (type I) and\u002For percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current indication for coronary revascularization.\n2. Cardiac resynchronization therapy initiated within 3 months prior to screening.\n3. Advanced heart failure defined as one or more of the following:\n\n   1. ACC\u002FAHA\u002FESC Stage D HF or non-ambulatory NYHA Class IV HF.\n   2. Inotropic infusion (continuous or intermittent) within 6 months prior to screening.\n   3. Subject is on the cardiac transplant waiting list.\n   4. Presence of or prior history of mechanical circulatory support for HF.\n4. Poor left heart compliance as determined by pulse-wave Doppler transmitral early-to-late (E\u002FA) ratio \\>2.0 assessed by the screening echocardiogram. The Screening Committee will evaluate left heart function if the transmitral A velocity is not measurable or absent.\n5. Right heart dysfunction defined as tricuspid annular plane systolic excursion (TAPSE) \\\u003C12 mm or right ventricular (RV) fractional area change (FAC) \\\u003C25% assessed by the screening echocardiogram.\n6. Body mass index (BMI) \\>45 kg\u002Fm2.\n7. 6-minute walk test distance \\\u003C100 meters OR \\>450 meters.\n8. Admission for HF within the 30 days prior to planned index procedure.\n9. Any known history of orthostatic hypotension or orthostatic hypotension at the time of screening (regardless of the presence of symptoms). Orthostatic hypotension is defined as a systolic blood pressure (BP) decrease of \\>20 mmHg upon going from supine to standing position or undergoing treatment with Midodrine.\n10. Orthostatic pulse pressure change from supine to standing decrease of \\>10mmHg in the absence of a HR increase \\>15bpm\n11. Postural orthostatic tachycardia syndrome or preload insufficiency syndrome.\n12. Systolic BP \\\u003C100 mmHg or \\>170 mmHg despite appropriate medical management.\n13. Baseline screening ECG resting HR \\>100 beats per minute or ventricular tachycardia.\n14. Catheter ablation for atrial fibrillation within 6 months prior to screening or planned in the next 12 months at the time of screening.\n15. Left ventricular EF \\\u003C40% within the 3 years prior to screening unless reduced EF was transient and associated with an acute event.\n16. Presence of significant valve disease defined by the site cardiologist as:\n\n    1. Greater than mild mitral valve stenosis.\n    2. Greater than moderate mitral valve regurgitation.\n    3. Greater than moderate-to-severe tricuspid valve regurgitation.\n    4. Greater than moderate aortic valve stenosis or regurgitation.\n17. Known hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative cardiomyopathy (e.g., hemochromatosis, sarcoidosis).\n18. History of clinically significant liver cirrhosis.\n19. Prior weight loss surgery\n20. Dialysis dependent; or estimated GFR \\\u003C25 ml\u002Fmin\u002F1.73 m2 by CKD-EPI creatinine equation.\n21. Arterial oxygen saturation \\\u003C90% on room air.\n22. Chronic pulmonary disease requiring continuous home oxygen OR hospitalization for exacerbation of chronic pulmonary disease (including intubation) in the 12 months before study entry OR known history of GOLD Class III or worse chronic obstructive pulmonary disease (COPD).\n23. Participating in conflicting investigational drug or device study that is not completed within 30 days prior to the screening visit.\n24. Life expectancy \\\u003C12 months for non-cardiovascular reasons.\n25. Any condition, or history of illness or surgery that, in the opinion of the site investigator or Screening Committee, might confound the results of the study or pose additional risks to the patient.\n26. Females who are pregnant or lactating or planning to become pregnant during the next year.\n27. Any of the following measured by screening right heart catheterization:\n\n    1. Mean right atrial pressure (RAP) \\>20 mmHg at rest\n    2. Cardiac index \\\u003C2.0 L\u002Fmin\u002Fm2 at rest\n    3. Pulmonary vascular resistance (PVR) \\>4 Wood units\n\n    Exclusion Criteria Assessed During the index procedure:\n28. Vessel tortuosity or variant vascular anatomy that could preclude the access or maneuvering of the interventional device from the access site to target vessel. This includes previous spine surgery that may impact the ability to access and treat the target sites of T11 and T10.",{"count":230,"type":22},[25],"The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve. The study includes people who have heart failure with preserved ejection fraction (HFpEF). The goal is to learn whether this procedure, performed using the Satera Ablation System, may help improve symptoms and to better understand which patients may benefit most from this treatment in the future.",[208],[435,103,476,477],"Greater Splanchnic Nerve","GSN","2026-03-10",{"date":480,"type":39},"2026-03-13",{"date":482,"type":39},"2020-12-18",{"date":484,"type":22},"2029-08-10",{"name":486,"class":46},"Axon Therapies, Inc.",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":18,"minAge":495,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":498,"conditions":499,"keywords":502,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":138},"100586000","ai-based-monitoring-system-for-chronic-heart-failure-with-advanced-wearable-and-mini-invasive-devices-100586000","NCT06909682","AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices","Smart Monitoring and Analysis System Based on Artificial Intelligence for Patients With Chronic Heart Failure Using Advanced Mini-Invasive and Wearable Medical Devices","SMART-CARE","Inclusion Criteria\n\n* Age ≥ 18 years (adults of any sex)\n* Confirmed diagnosis of chronic heart failure (CHF) for at least 6 months prior to screening\n* Stable on optimized heart failure therapy for at least one month before enrollment\n* Any left ventricular ejection fraction (LVEF) classification, including:\n\n  * Heart Failure with Reduced Ejection Fraction (HFrEF)\n  * Heart Failure with Mid-Range Ejection Fraction (HFmrEF)\n  * Heart Failure with Preserved Ejection Fraction (HFpEF)\n* NYHA Functional Class I, II, or III\n* History of at least one hospital admission or outpatient visit in the past 12 months requiring intravenous (IV) diuretics, vasodilators, or inotropes for CHF exacerbation\n* Ability to provide written informed consent or availability of a legally authorized representative Exclusion Criteria\n* NYHA Functional Class IV or anticipated heart transplant or ventricular assist device (VAD) implantation within 6 months of screening\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or dialysis dependence\n* Terminal comorbidities (e.g., advanced cancer, end-stage pulmonary disease) significantly limiting life expectancy\n* Pregnancy\n* Presence of skin conditions or allergies preventing prolonged use of a wearable device\n* Inability to comply with study procedures (e.g., cognitive impairment, significant psychiatric disorders)","19 Years",{"count":497,"type":22},205,"The goal of this observational, multicenter study is to evaluate whether AI-driven remote monitoring using a mini-invasive wearable device can improve clinical outcomes in adult patients (≥18 years) with chronic heart failure (CHF).\n\nThe main questions it aims to answer are:\n\n* Can continuous remote monitoring reduce hospital admissions (emergency visits and hospitalizations) by 20% compared to standard care?\n* Does wearable-based remote monitoring improve functional, biochemical, and instrumental parameters in CHF patients? Researchers will compare patients using the wearable device (intervention group) to those receiving standard clinical follow-up (control group) to assess whether AI-driven monitoring leads to fewer hospitalizations, better disease management, and improved quality of life.\n\nParticipants will:\n\n* Wear the EmbracePlus (Empatica Inc.) device continuously for six months (intervention group only).\n* Have their biometric data (SpO₂, HRV, EDA, respiratory rate, temperature, sleep quality) monitored remotely.\n* Receive automated alerts and teleconsultations if abnormal physiological changes are detected.\n* Attend scheduled follow-up visits (remote and in-person) for clinical evaluation and treatment adjustments.\n\nThe study aims to provide real-world evidence on whether integrating wearable health technology with AI analytics can enhance CHF management and improve patient outcomes.",[182,500,399,64,501],"Cardiovascular Diseases","Congestive Heart Failure Chronic",[503,504,505,506,507,508,509,510,511,512,513,514,515],"Wearable Medical Devices","Remote Patient Monitoring","Artificial Intelligence in Cardiology","Smart Wearables for Healthcare","Observational Study in Heart Failure","AI-Based Predictive Modeling","Telemedicine in Heart Failure","Non-Invasive Health Monitoring","Personalized Medicine for CHF","Quality of Life Improvement in Heart Failure","Heart Failure Readmission Prevention","Telehealth in Chronic Disease Management","Digital Health Solutions for Heart Disease","2026-03-09",{"date":518,"type":39},"2026-03-11",{"date":520,"type":39},"2025-08-01",{"date":522,"type":22},"2027-02-02",{"name":524,"class":82},"University of Salerno",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":222},"100625958","data-driven-phenotyping-in-heart-failure-with-preserved-ejection-fraction-100625958","NCT07429396","Data-Driven Phenotyping in Heart Failure With Preserved Ejection Fraction","Inclusion Criteria\n\n1. Retropective observational phase (Phase I):\n\n   * Age ≥18 years;\n   * Established diagnosis of heart failure with preserved ejection fraction (LVEF ≥50%);\n   * Patients receiving care (outpatient or inpatient) at the Local Health Unit of the Leiria Region (ULS RL) since September 2018.\n2. Cross-sectional observational phase (Phase II - CPET):\n\n   * Age ≥18 years;\n   * Established diagnosis of HFpEF;\n   * Selection as a volunteer representative of phenotypes identified in the retrospective clustering analysis;\n   * Provision of written informed consent prior to any study-specific procedures.\n\nExclusion Criteria:\n\n1. Retropective observational phase (Phase I):\n\n   * Incomplete or inadequate medical records preventing full data extraction.\n2. Cross-sectional observational phase (Phase II - CPET):\n\n   * Medical contraindication or physical inability to perform cardiopulmonary exercise testing (CPET);\n   * Inability to provide informed consent.",{"count":59,"type":22},"The goal of this observational study is to learn how people with Heart Failure with Preserved Ejection Fraction (HFpEF) can be grouped into different \"phenotypes\" based on their clinical information. The researchers want to understand whether these groups have different health profiles and different responses during a cardiopulmonary exercise test (CPET).\n\nThe main questions this study aims to answer are:\n\n* Can clinical data be used to identify meaningful HFpEF phenotypes?\n* Do these phenotypes match well-known HFpEF scores, such as the H2FPEF and Heart Failure Association Pre-test Assessment, Echocardiography and Natriuretic Peptide (HFA-PEFF) scores?\n* Do people in different phenotypes show different results on a CPET?\n\nParticipants will:\n\n* Have their past clinical records reviewed if they were diagnosed with HFpEF at the Local Health Unit of the Leiria Region (ULS RL);\n* A smaller group will attend one visit to complete a CPET, which measures how the heart, lungs and muscles respond during exercise.\n\nThis study includes adults aged 18 years or older who have HFpEF. The study does not involve any new treatments or experimental drugs.",[30,534,64],"Heart Failure, Diastolic",[30,103,536,98,537,538,539,540,541,542],"Preserved Ejection Fraction","Machine Learning","Data-driven clustering","Cardiopulmonary Exercise Testing","H2FPEF score","HFA-PEFF score","Exercise tolerance","2026-02-20",{"date":545,"type":39},"2026-02-24",{"date":547,"type":22},"2026-12-01",{"date":549,"type":22},"2028-05-31",{"name":551,"class":82},"Instituto Politécnico de Leiria",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":138},"100613923","treating-atrial-fibrillation-in-heart-failure-with-preserved-ejection-fraction-ablation-or-medication-100613923","NCT07272902","Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication","A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and Preserved Ejection Fraction (CABANA-RAFT HF): A Pilot Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of atrial fibrillation (documented on Holter, rhythm strip, or ECG)\n* New York Heart Association (NYHA) class II-III heart failure\n* Left ventricular ejection fraction (LVEF) \\>40%\n* Meet specific NT-proBNP criteria:\n* If HF hospitalization within 6 months prior to screening: NT-proBNP \\>200 pg\u002Fml (if not in AF at screening) or \\>600 pg\u002Fml (if in AF at screening)\n* Otherwise: NT-proBNP \\>300 pg\u002Fml (if not in AF at screening) or \\>900 pg\u002Fml (if in AF at screening)\n* On stable guideline-directed medical therapy for ≥1 month\n* On stable diuretic dose for ≥2 weeks\n* Suitable for either ablation-based rhythm control or rate control strategy\n\nExclusion Criteria:\n\n* Permanent atrial fibrillation diagnosis\n* Prior catheter ablation for atrial fibrillation\n* NYHA class IV heart failure\n* Rheumatic heart disease\n* Moderate or severe mitral stenosis\n* Mechanical mitral valve\n* Severe aortic stenosis or severe aortic\u002Fmitral regurgitation\n* Renal failure requiring dialysis\n* Contraindication to oral anticoagulation\n* Infiltrative cardiomyopathies\n* Complex congenital heart disease\n* Untreated thyroid disease\n* Acute coronary syndrome or coronary artery bypass surgery within 12 weeks\n* Participation in another clinical trial\n* Inability to provide informed consent\n* Other serious non-cardiovascular condition with life expectancy ≤1 year\n* Age \\\u003C18 years",{"count":560,"type":22},84,[25],"This study is testing two different ways of treating atrial fibrillation (AF) in people who also have heart failure with mildly reduced or preserved heart function. Patients will randomly be assigned to either rhythm control using catheter ablation or rate control using medicines. The pilot phase will determine if a larger study can be successfully carried out to see which approach better improves survival, reduces hospitalizations, and enhances quality of life.",[332,400,64,564,565],"Rate Control","Rhythm Control","2026-02-12",{"date":568,"type":39},"2026-02-17",{"date":570,"type":39},"2026-01-01",{"date":572,"type":22},"2027-10",{"name":574,"class":82},"Nova Scotia Health Authority",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":582,"sex":18,"minAge":56,"maxAge":147,"enrollmentInfo":583,"targetDuration":584,"studyType":94,"phases":4,"briefSummary":585,"conditions":586,"keywords":588,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":599,"leadSponsor":601,"locationsCount":138},"100620243","precision-subtyping-and-prognostic-study-of-heart-failure-based-on-multi-omics-integration-and-clinical-indicators-a-prospective-single-center-cohort-study-100620243","NCT07355088","Precision Subtyping and Prognostic Study of Heart Failure Based on Multi-Omics Integration and Clinical Indicators: A Prospective Single-Center Cohort Study","HF-MultiOmics","Inclusion Criteria:(1)For chronic heart failure (CHF) patients:1.Meet the 2022 European Society of Cardiology (ESC) diagnostic criteria for CHF, classified into heart failure with reduced ejection fraction (HFrEF), heart failure with mildly reduced ejection fraction (HFmrEF), and heart failure with preserved ejection fraction (HFpEF) per ESC guidelines;2.Aged 18 to 80 years (inclusive);3.Able to provide written informed consent independently (or via a legal guardian if cognitively impaired, with a Mini-Mental State Examination \\[MMSE\\] score ≥ 24).\n\n(2)For healthy controls:1.No history of cardiovascular disease, confirmed by medical history review and baseline echocardiography;2.Aged 18 to 80 years (inclusive), matched 1:2 with CHF patients by age and gender;3.Able to provide written informed consent.\n\nExclusion Criteria:(1)Acute decompensated heart failure (admitted for acute HF exacerbation within 72 hours prior to enrollment);(2)End-stage renal disease, defined as an estimated glomerular filtration rate (eGFR) \\\u003C 15 mL\u002Fmin\u002F1.73m² (confirmed by serum creatinine testing);(3)Active malignancies (receiving systemic treatment within 6 months prior to enrollment) or severe systemic diseases (e.g., severe liver failure, active autoimmune diseases);(4)Antibiotic use within 2 weeks prior to enrollment (may interfere with gut microbiome analysis);(5)Inability to complete 12-month follow-up (e.g., planned long-term overseas residence) or provide required biological samples (e.g., venous blood, fecal samples).",true,{"count":359,"type":22},"12 Months","This is a prospective single-center cohort study conducted at The First Affiliated Hospital of Xinjiang Medical University, aiming to enroll 400 patients with chronic heart failure (including HFrEF, HFmrEF, HFpEF) and 200 healthy controls.We will collect clinical data (e.g., NYHA class, NT-proBNP), multi-omics samples (genome, proteome, metabolome, gut microbiome), and imaging indicators (e.g., EAT density, myocardial strain) from participants at baseline. For patients treated with SGLT2 inhibitors, we will also track dynamic changes in multi-omics during follow-up.The main purpose is to build a composite risk prediction model (integrating multi-omics and clinical indicators) to predict the 1-year composite endpoint (heart failure rehospitalization or all-cause death). Secondary goals include identifying specific molecular profiles related to heart failure phenotypes, exploring the \"gut-heart axis\" mechanism, and finding early biomarkers for SGLT2 inhibitor response.All participants will be followed up for at least 12 months, and the study will strictly comply with ethical norms and protect the privacy of participants.",[182,399,64,587],"Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)",[182,589,590,591,592,593,594],"Multi-omics","Gut-heart axis","SGLT2 inhibitors","Risk prediction model","Epicardial Adipose Tissue","Myocardial Strain","2026-01-12",{"date":597,"type":39},"2026-01-21",{"date":570,"type":22},{"date":600,"type":22},"2028-03-01",{"name":602,"class":82},"Xinjiang Medical University",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":138},"100468707","characteristics-phenotypes-and-traits-of-heart-failure-with-preserved-ejection-fraction-traits-hfpef-100468707","NCT05383287","Characteristics, Phenotypes, and TRAITS of Heart Failure With Preserved Ejection Fraction (TRAITS-HFpEF)","TRAITS-HFpEF","Inclusion Criteria:\n\n* Patients attending the HFpEF clinic at MFT.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Imprisonment\n* Inability to provide full written or verbal informed consent in English",{"count":611,"type":22},1250,"Heart failure with preserved ejection fraction (HFpEF), a certain type of heart failure, occurs when the heart doesn't pump blood around the body properly. It can cause breathlessness, tiredness, and swollen feet or ankles. It is not clear why people develop HFpEF and treatment options are very limited.\n\nTRAITS-HFpEF is a study that aims to understand why people develop HFpEF, identify new tests and treatments, and gain information on the life expectancy of people living with this condition. It will do this by routinely collecting information on people attending a specialised outpatient HFpEF clinic.",[28],"2025-09-26",{"date":616,"type":39},"2025-10-01",{"date":618,"type":39},"2022-08-12",{"date":620,"type":22},"2029-10",{"name":622,"class":623},"Manchester University NHS Foundation Trust","OTHER_GOV",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":18,"minAge":631,"maxAge":147,"enrollmentInfo":632,"targetDuration":4,"studyType":23,"phases":634,"briefSummary":635,"conditions":636,"keywords":637,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":138},"100425643","exercise-capacity-according-to-coronary-microvascular-dysfunction-and-body-composition-100425643","NCT04822649","Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition","Differences in Cardiopulmonary Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition in Patients With Suspected Heart Failure With Preserved Ejection Fraction","Inclusion Criteria:\n\n* Age 20 to 80\n* Typical\u002Fatypical chest pain or ischemic symptoms including dyspnea\n* No significant coronary artery stenosis (\\>50% stenosis) in coronary angiography or computed tomography\n* Left ventricular ejection fraction ≥50%\n\nExclusion Criteria:\n\n* More than moderate valvular heart disease\n* Congenital heart disease\n* Chronic renal failure (estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73m2) or end-stage renal failure undergoing hemodialysis or peritoneal dialysis\n* Asthma, chronic obstructive pulmonary disease and primary pulmonary hypertension\n* Receiving anticancer drugs\n* Vasculitis associated with autoimmune diseases\n* Patients with difficulty in performing exercise load evaluation (treadmill, bicycle ergometer)\n* Atrial fibrillation\n* Atrioventricular block with more than second degrees, symptomatic bradycardia, cryo-node failure syndrome, Wolff-Parkinson-White (WPW) patients","20 Years",{"count":633,"type":22},100,[25],"The correlation of coronary microvascular function and body composition with cardiopulmonary exercise capacity will be assessed in patients with heart failure with preserved ejection fraction.",[28],[638],"body composition, CPET, CFR, coronary microvascular dysfunction (CMD), frailty, HFpEF","2025-08-25",{"date":641,"type":39},"2025-09-02",{"date":643,"type":39},"2021-04-15",{"date":645,"type":22},"2025-12-31",{"name":647,"class":82},"Korea University Anam Hospital",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":656,"enrollmentInfo":657,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":658,"conditions":659,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":138},"100589603","platelet-derived-growth-factor-receptor--pdgfr-imaging-in-cardiac-fibrosis-100589603","NCT06956560","Platelet Derived Growth Factor Receptor ß (PDGFRß) Imaging in Cardiac Fibrosis","Microdosing, Non-randomized, Clinical Trial to Investigate Binding of Positron Emission Tomography Tracer [68ga]Ga-DOTA-Cys-ATH001 Targeting Platelet-derived Growth Factor Receptor Beta (PDGFRß) in Healthy Subject as Compared to Patients With Cardiac Fibrosis.","PARIS","Inclusion Criteria:\n\n* Willing and able to give written informed consent for participation in the trial and able to comply with all trial procedures and requirements.\n* Male or female participant aged 40 to 70 years, inclusive, at the screening visit.\n* Women of childbearing potential must practice abstinence from heterosexual intercourse or must agree to use a highly effective method of contraception.\n\nCohort-specific inclusion criteria:\n\nCohort 1, STEMI high-risk patients:\n\n* NT-proBNP \\>500 pg\u002FmL within 48 hrs after PCI\n* Post-PCI Thrombolysis In Myocardial Infarction (TIMI) score \\\u003C3.\n* No previous history of coronary artery disease or heart failure.\n\nCohort 2, STEMI low-risk patients\n\n* NT-proBNP \\\u003C500 pg\u002FmL within 48 hrs after PCI\n* Post-PCI TIMI score 3.\n* No previous history of coronary artery disease or heart failure.\n\nCohort 3 (HFpEF patients)\n\n* Presence of signs and symptoms of HF\n* Ejection Fraction ≥50%\n* Elevated levels of natriuretic peptides (NT-proBNP≥125pg\u002FmL)\n* At least one of the following:\n* Relevant structural heart disease (left ventricular hypertrophy or left atrial enlargement)\n* Diastolic dysfunction\n\nCohort 4 (healthy participants)\n\n* Individuals with no history of coronary disease or heart failure.\n* Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.\n\nExclusion Criteria:\n\n* Any contraindication for MRI according to a standard checklist\n* Having worked as a metal worker or welder.\n* Contraindication for gadolinium-based contrast agents such as risk of nephrogenic systemic fibrosis (NSF) or allergy to gadolinium.\n* Kidney dysfunction measured as estimated Glomerular filtration rate (eGFR)\\\u003C30 mL\u002Fmin\u002F1.73m2\n* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the participant's ability to participate in the trial.\n* Any clinically significant illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the screening visit.\n* Any malignancy within the past 12 months before the screening visit, with the exception of successfully treated basal cell carcinoma of the skin or in situ prostate cancer under active surveillance, with no interventions scheduled during the period of trial participation.\n* Any active gastrointestinal hemorrhage in the past six months.\n* Acute or chronic disabling stroke.\n* Aortic aneurysm or aortic dissection.\n* Hypertensive crisis.\n* Circulatory unstable condition in need for mechanical support.\n* Any planned major surgery within the duration of the trial participation.\n* Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.\n* Poor peripheral venous access, as judged by the Investigator.\n* The participant has any laboratory abnormality or condition that, in the Investigator's opinion, could adversely affect the safety of the participant or impair the assessment of trial results.\n* The participant is using any prohibited concomitant medications as described in the protocol, at the discretion of the Investigator.\n* The Investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements.\n\nAdditional exclusion criteria for all participants (cohorts 1,2 and 4):\n\n* History of coronary artery disease or heart failure.","70 Years",{"count":328,"type":22},"An observational, cross-sectional, longitudinal, microdosing Position Emission Tomography (PET) imaging study to investigate platelet derived growth factor receptor beta (PDGFRß) expression in the heart of patients with high or low risk of heart failure after a ST-Elevation Myocardial Infarction (STEMI) after a percutaneous coronary intervention (PCI) with a stent procedure, as well as in patients with heart failure with preserved ejection fraction (HFpEF) and healthy individuals.",[660,28],"ST-Elevation Myocardial Infarction (STEMI)","2025-08-04",{"date":663,"type":39},"2025-08-08",{"date":665,"type":39},"2025-06-01",{"date":667,"type":22},"2026-12",{"name":669,"class":82},"Uppsala University",{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":4,"eligibilityCriteria":676,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":677,"targetDuration":4,"studyType":23,"phases":679,"briefSummary":680,"conditions":681,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":138},"100582407","phase-2-a-study-of-ibi362-in-subjects-with-hfpef-or-hfmref-combined-with-obesity-100582407","NCT06862908","A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity","A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Subjects With HFpEF（Heart Failure With Preserved ejectIon Fraction）or HFmrEF（Heart Failure With Mildly Reduced Ejection Fraction）Combined With Obesity","Inclusion criteria:\n\n1. Age ≥18 at the time of signing the informed consent.\n2. BMI≥28kg\u002Fm2.\n3. NYHA class II-III.\n4. There were no hospitalizations due to heart failure at screening visit (V1) to randomized visit (V2).\n5. KCCQ-CSS score \\\u003C 80 during the screening period and before randomization.\n6. Medication for chronic diseases: If used before screening, the dose should be stable for ≥4 weeks; If not used before screening, the drug should also be stopped for ≥4 weeks.\n7. The women of childbearing potential（WOCBP） agrees to use the contraceptive method prescribed in this protocol for the entire study period and for 3 months after the final treatment. Pregnancy test results for fertile women during the screening period must be negative. Female subjects should not breastfeed.\n8. Voluntarily sign the informed consent form, and be willing to strictly abide by the requirements and restrictions of the informed consent form and the protocol throughout the study period, including but not limited to: maintaining a stable diet and exercise lifestyle, injecting the study drugs as planned, and keeping a study diary.\n\nExclusion criteria:\n\n1. myocardial infarction, stroke, or transient ischemic attacks, hospitalization for acute heart failure requiring any ventilatory and circulatory support devices (such as IABP ,I MPELLA, ECMO, CRRT, etc.) within 3 months before screening.\n2. Unstable angina pectoris or HF decompensation requiring IV diuretics, IV inotropes, or IV vasodilators within 30 days before screening.\n3. Poorly controlled hypertension at the screening stage, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg. Or systolic blood pressure \\\u003C 90mmHg during screening.\n4. Had previously undergone or planned to undergo bariatric surgery during the study period.\n5. The presence of endocrine diseases or medical history that may significantly affect body weight.\n6. Previous diagnosis of type 1 diabetes or specific type diabetes.\n7. Use of GLP-1R agonists or glucagon receptor (GLP-1R\u002FGCGR) agonists or GIPR (Glucagon dependent insulinotropic polypeptide) within 3 months before screening receptor) \u002FGLP-1R agonist or GIPR\u002FGLP-1R\u002FGCGR agonist; Participants who stopped using these drugs more than 3 months prior to screening due to lack of efficacy or intolerance should also be excluded.\n8. Use of insulin in the 3 months prior to screening to control diabetes, except for short-term (cumulative ≤14 days) use of insulin in acute conditions, such as acute illness, hospitalization, or elective surgery. The last insulin treatment was less than 14 days from the screening date.\n9. History of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or family history.\n10. Clinically significant gastric empting abnormalities (such as severe diabetic gastroparesis, gastric pyloric obstruction, etc.) or gastrointestinal surgery.\n11. Active or untreated malignancies were present within 5 years prior to screening, or clinical malignancies were in remission (except in subjects with no recurrence after surgery for basal cell and squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the prostate, or papillary thyroid carcinoma).\n12. A history of atopic reactions (clinical manifestations of severe or multiple allergies) or a history of clinically significant multiple or severe drug allergies, or intolerance to local glucocorticoids, Or severe post-treatment hypersensitivity reactions (including but not limited to erythema multiforme, linear immunoglobulin A dermatitis, toxic epidermal necrolysis, anaphylaxis, angioedema, or exfoliative dermatitis).\n13. History of organ transplantation (except corneal transplantation, autologous skin transplantation), or preparing to receive organ transplantation.\n14. The investigators identified major surgeries that might be planned during the study period that would affect the participants' ability to walk.\n15. Past suicidal thoughts or behaviors.\n16. The investigator believes that the subjects are not suitable to participate in the study because of any other factors (including previous serious mental illness) that may affect the efficacy, safety evaluation or compliance of the study.",{"count":678,"type":22},141,[179],"This is a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of IBI362 in Chinese subjects with heart failure with ejection fraction retention\u002Fmild ejection fraction reduction (HFpEF\u002FHFmrEF) combined with obesity (BMI≥28kg\u002F㎡). This study will enroll about 141 NYHA Class II-III HFpEF\u002FHFmrEF subjects combined with obesity. Eligible participants will be randomly assigned to IBI362 4 mg, IBI362 6 mg, or placebo at a ratio of 1:1:1, randomized by concomitant atrial fibrillation during screening (history\u002Fscreening ECG).\n\nThe trial period includes a 2-week screening period, a 52-week double-blind treatment period, and a 4-week safety follow-up period.",[100,64,400],{"date":683,"type":39},"2025-07-11",{"date":685,"type":39},"2025-04-01",{"date":687,"type":22},"2027-02-11",{"name":689,"class":46},"Innovent Biologics (Suzhou) Co. Ltd."]