[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hfpef---heart-failure-with-preserved-ejection-fraction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hfpef---heart-failure-with-preserved-ejection-fraction":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,69,100,130,162,188,214,241,271,292,321,343,367],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":41,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100569808","ai-enabled-direct-from-ecg-ejection-fraction-ef-severity-assessment-using-cor-ecg-wearable-monitor-100569808",false,"NCT06699056","AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor","AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Using COR ECG Wearable Monitor","EFACT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able and eligible to wear a Holter monitor\n\nExclusion Criteria:\n\n* Receiving mechanical respiratory or circulatory support, or renal support therapy, at the time of screening or during Visit #1\n* Any condition that, in the investigator's opinion, could interfere with compliance with the study protocol or pose a safety risk to the participant\n* History of poor tolerance or severe skin reactions to ECG adhesive materials",true,"ALL","18 Years",{"count":21,"type":22},2000,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood.\n\nIn this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Ventricular Ejection Fraction","LVF","LV Dysfunction","Atrial Enlargement","Conduction Defect","Heart Failure","Valvular Heart Disease","Ischemic Heart Disease","Cardiotoxicity","Myocardial Infarction","Dilated Cardiomyopathy","HFrEF - Heart Failure With Reduced Ejection Fraction","HFpEF - Heart Failure With Preserved Ejection Fraction","Syncope","Remodeling, Cardiac",[42,43,44,45,46,47,48,28,49,50,51,52,53,54,29,55],"ECG Patch","LVEF","Holter","ECG Wearable","COR","Atrial Conduction","ECG Biomarker","SaMD","Clinical Decision Support","ECG","EF Severity","Ejection Fraction","AI","Electrical Remodeling","RECRUITING","2026-05-28",{"date":59,"type":60},"2026-06-01","ACTUAL",{"date":62,"type":60},"2024-11-21",{"date":64,"type":22},"2027-11-15",{"name":66,"class":67},"Peerbridge Health, Inc","INDUSTRY",8,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100574721","phase-2-cameo-fontan--dapagliflozin-in-the-failing-fontan-circulation-100574721","NCT06762964","CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation","Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study","Inclusion Criteria\n\n1. Signed informed consent prior to any study specific procedures\n2. History of Fontan procedure\n3. Male or female subject\n4. Age ≥ 18\n5. Symptoms of dyspnea (NYHA II-IV) with no non-cardiac or ischemia explanation\n6. Elevated peripheral venous pressure (PVP) at rest or during exercise (≥20 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized.\n\nExclusion Criteria\n\n1. Type I diabetes\n2. Any of the following medications: Insulin or Pramlintide, Sandostatin, Akeega (abiraterone acetate), Growth Hormone (Somatogrogon-GHLA), Lithium, Chloroquine, Hydroxychloroquine, Thioctic acid (alpha lipoic acid), Empagliflozin or Canagliflozin\n3. Recent hospitalization (\\\u003C30 days) or revascularization (\\\u003C90 days)\n4. Significant valvular heart disease (≥moderate stenosis, \\>moderate regurgitation)\n5. Significant Fontan obstruction with resting SVC-IVC gradient \\>4 mmHg\n6. Primary cardiomyopathy (such as amyloid)\n7. Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator\n8. Severe anemia (hemoglobin \\\u003C9 gm\u002Fdl)\n9. Severe kidney disease (estimated GFR\\\u003C30) or liver disease\n10. Women of childbearing potential not willing to use a medically accepted method of contraception OR who are currently pregnant (confirmed with positive pregnancy test) or breast feeding.\n11. History of serious hypersensitivity reaction to dapagliflozin\n12. Subjects on dialysis\n13. Subjects with severe liver disease with history of decompensation including ascites or encephalopathy or variceal bleeding\n14. Single ventricle heart disease without Fontan palliation\n15. Those with a history of Fontan takedown",{"count":77,"type":22},27,"INTERVENTIONAL",[80],"PHASE2","The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.",[83,84,38],"Fontan Circulation","Single Ventricle Heart Disease",[86,87,88],"Fontan","HFpEF","SGLT2 inhibitors","2026-05-05",{"date":91,"type":60},"2026-05-06",{"date":93,"type":60},"2025-05-16",{"date":95,"type":22},"2027-02",{"name":97,"class":98},"Mayo Clinic","OTHER",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":18,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":78,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100639850","phase-3-finerenone-in-patients-undergoing-transcatheter-aortic-valve-implantation-with-heart-failure-100639850","NCT07575672","Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure","Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure: A Prospective, Multicenter, Randomized, Placebo-Controlled Trial","FINE-VALUE","Inclusion Criteria:\n\n1. Age ≥ 65 years.\n2. Patients with severe aortic stenosis (aortic valve area \\\u003C 1.0 cm2 or indexed area \\\u003C 0.6 cm2\u002Fm2, or mean transvalvular aortic gradient ≥ 40 mmHg or velocity of blood flow through the valve ≥ 4.0 m\u002Fs) undergoing transfemoral TAVI.\n3. New York Heart Association class ≥ II.\n4. Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.\n5. Informed consent has been signed.\n\nExclusion Criteria:\n\n1. Untreated serum\u002Fplasma potassium \\> 5.0 mmol\u002FL during the screening period or randomization visit.\n2. Estimated glomerular filtration rate \\\u003C 25 ml\u002Fmin\u002F1.73 m².\n3. Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.\n4. Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.\n5. Pregnant or breastfeeding patients.\n6. Life expectancy \\\u003C 1 year.\n7. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.","65 Years",{"count":110,"type":22},2832,[112],"PHASE3","This study is a multicenter, double-blind, randomized, placebo-controlled trial. The purpose is to evaluate whether treatment with finerenone in patients with symptomatic severe aortic stenosis undergoing TAVI, and heart failure with LVEF ≥40% is associated with a reduction in the composite endpoint of all-cause mortality or worsening of heart failure. Participants are patients with symptomatic aortic stenosis undergoing TAVI and heart failure with LVEF≥40%. Eligible patients will be randomly assigned in a 1:1 ratio to either the finerenone group or the placebo group. Patients meeting all inclusion criteria and not any exclusion criteria will be invited to participate before discharge. All enrolled patients will consecutively receive treatment, during which serum potassium and estimated glomerular filtration rate will be closely monitored. Follow-up will be conducted at 30 days, 12 months at clinic, and 3 months, 6 months, 9 months and every 6 months after 12 months of enrollment online or via telephone (at clinic if necessary). The final visit will be conducted for all enrolled patients at the end of the study.",[38,115,116],"TAVI(Transcatheter Aortic Valve Implantation)","Finerenone",[87,118,116],"TAVI","NOT_YET_RECRUITING","2026-05-04",{"date":122,"type":60},"2026-05-08",{"date":124,"type":22},"2026-07-01",{"date":126,"type":22},"2029-12-31",{"name":128,"class":98},"Second Affiliated Hospital, School of Medicine, Zhejiang University",61,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":18,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":78,"phases":142,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":99},"100624949","can-tiny-bubbles-offer-an-alternative-to-catheters-for-assessing-pressures-inside-the-heart-investigating-ultrasound-contrast-agents-as-pressure-sensors-against-gold-standard-catheter-pressures-in-cardiac-catheterisation-patients-100624949","NCT07416279","Can Tiny Bubbles Offer an Alternative to Catheters for Assessing Pressures Inside the Heart? Investigating Ultrasound Contrast Agents as Pressure Sensors Against Gold Standard Catheter Pressures in Cardiac Catheterisation Patients.","Intracardiac Pressures From Microbubbles Instead of a Catheter: First in Human Study and Signal Calibration","SonoHeart","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent to participate in the study\n* Patients who require a cardiac catheterisation procedure as part of their standard medical care\n* Good acoustic windows for echocardiography when lying flat on their back\n\nExclusion Criteria:\n\n* Known previous allergy to SonoVue, used in ultrasound contrast scans\n* Known allergy to any of the components of SonoVue microbubbles, for example, sulphur hexafluoride or polyethylene glycol (PEG), also known as macrogol, which is in bowel preparations used during colonoscopy and certain laxatives\n* A hole in their heart that lets blood flow from the right side to the left, skipping the lungs\n* Very high blood pressure in the arteries of the lungs (severe pulmonary hypertension)\n* Uncontrolled high blood pressure (hypertension)\n* Adult respiratory distress syndrome (ARDS; where severe lung inflammation prevents enough oxygen from reaching the body)\n* Current use of the medicine dobutamine (used to treat heart failure), or have been advised not to take dobutamine\n* Moderate to severe heart valve disease that could affect the catheter measurements\n* Recent acute coronary syndrome or unstable ischaemic cardiac disease, where blood flow to the heart muscle is reduced\n* Pregnant or may be pregnant\n* Participation in a clinical trial of a medicine within the past four months, to avoid any possible interactions with SonoVue\n* Participating in other research that would prolong their cardiac catheterisation procedure, to ensure that the overall process does not become too tiring or burdensome","21 Years","81 Years",{"count":141,"type":22},10,[143],"NA","The goal of this clinical trial is to investigate if ultrasound contrast agents can be used to estimate filling pressures inside the heart in patients with suspected heart disease. The main questions it aims to answer are:\n\n* Is there a strong correlation between the contrast signal and filling pressures inside the heart?\n* What is the calibration approach to convert the contrast signal from dB to a measure of pressure in mmHg?\n\nResearchers will compare the contrast signal with reference pressures measured using a catheter to see if it can be used to quantify filling pressures inside the heart.\n\nParticipants will:\n\n* Be exposed to a small amount of additional ionising radiation to guide a catheter in position inside the heart for reference pressures\n* Receive an ultrasound contrast agent at the clinically recommended dose and in line with clinical guidelines, via an intravenous line in their arm\n* Undergo contrast echocardiography - ultrasound scan of their heart with contrast\n* Undergo standard echocardiography - ultrasound scan of their heart without contrast",[38,146,147],"Cardiac Catheterisation","Heart Disease",[149,150,151,152],"Ultrasound contrast agents","Intracardiac filling pressures","Microbubble subharmonic signal","Echocardiography","2026-02-10",{"date":155,"type":60},"2026-02-18",{"date":157,"type":22},"2026-02",{"date":159,"type":22},"2027-03",{"name":161,"class":98},"King's College London",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":78,"phases":171,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100499553","heart-camp-connect--promoting-exercise-in-adults-with-heart-failure-with-preserved-ejection-fraction-100499553","NCT05784753","HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction","HEART (Heart Failure Exercise and Resistance Training) Camp Connect: Promoting Adherence to Exercise in Adults With Heart Failure With Preserved Ejection Fraction","Inclusion Criteria:\n\n* Diagnosis of heart failure with an ejection fraction greater than or equal to 50\n* Echocardiogram in prior 24 months\n* Stable pharmacologic therapy in the past 30 days\n* Any of the following evidence to confirm HFpEF - Score\\\u003C 6 on Heavy Hypertensive Atrial Fibrillation, Pulmonary Hypertension, Elder, Filling Pressure algorithm, invasive hemodynamic evidence of HFpEF(i.e., elevated pulmonary wedge pressure), or a confirmed clinical diagnosis of HFpEF\n\nExclusion Criteria:\n\n* Life-limiting illness precluding study completion\n* Clinical evidence of decompensated heart failure\n* Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents\n* Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks\n* Orthopedic or neuromuscular disorders preventing aerobic exercise\n* Cardiopulmonary exercise test results that preclude safe exercise\n* Unwilling\u002Funable to complete pre-randomization procedures\n* Pregnancy\n* Implantable cardioverter defibrillator",{"count":170,"type":22},300,[143],"The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.",[38],[175,176,177],"exercise training","patient adherence","coaching","2026-01-14",{"date":180,"type":60},"2026-01-16",{"date":182,"type":60},"2023-11-20",{"date":184,"type":22},"2028-03",{"name":186,"class":98},"University of Nebraska",3,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":78,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":99},"100566116","alex-dhf-ablation-and-exercise-in-diastolic-heart-failure-100566116","NCT06650995","AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure","AlEX-DHF","Inclusion Criteria:\n\n* Diagnosed heart failure with preserved ejection fraction\n* Symptomatic short-persistent atrial fibrillation (diagnosis within 1 year of study inclusion)\n\nExclusion Criteria:\n\n* Paroxysmal, long-persistent or permanent atrial fibrillation\n* Clinically unstable coronary artery disease or acute coronary syndrome\n* Physical and\u002For mental inability to perform exercise testing\n* Prior ablation therapy\n* Precapillary pulmonary hypertension at rest\n* Intracardiac shunts\n* Left ventricular ejection fraction \\\u003C50%\n* High-degree valve insufficiency or stenosis (greater than grade 1 at rest)","99 Years",{"count":197,"type":22},40,[143],"The investigators analyze the impact of exercise and ablation in patients with symptomatic short-persistent atrial fibrillation (Afib) and heart failure with preserved ejection fraction (HFpEF). It is hypothesized that the combination of ablation and exercise better improves peak oxygen consumption (VO2peak) through improvement of peripheral (exercise training) and central (ablation) adaptations.\n\nExercise intervention will contain a 12-week combined, video-based, supervised, endurance, resistance and respiratory training.",[38,201],"Atrial Fibrillation",[203,204],"exercise capacity","ablation","2025-12-18",{"date":207,"type":60},"2025-12-26",{"date":209,"type":22},"2026-02-01",{"date":211,"type":22},"2027-06-30",{"name":213,"class":98},"Technical University of Munich",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":78,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":99},"100610104","phase-2-tailored-exercise-training-study-among-adults-with-hfpef-100610104","NCT07223242","Tailored Exercise Training Study Among Adults With HFpEF","TEXPEF","Inclusion Criteria:\n\n1. Age\\>= 18 yrs\n2. LVEF (Left Ventricular Ejection Fraction) \\>= 50%\n3. History of HFpEF or at risk of HFpEF\n\n   1. HFpEF diagnosis based on:- -HF hospitalization within 12 months-\n\n      * NT-proBNP \\>360 pg\u002FmL\n   2. Risk of HFpEF based on:-\n\n      * \\>2 risk factors (h\u002Fo diabetes, hypertension, obesity, physical inactivity by self-report)\n4. SPPB \\\u003C 10 or VO2\\\u003C60th percentile\n5. BMI \\>=28 (for randomization in phase II)\n6. Able to use cell phone and mobile application\n\nExclusion Criteria:\n\n1. Hospitalization 1 month prior to baseline visit\n2. History of recurrent falls\n3. eGFR (Estimated Glomerular Filtration Rate) \\\u003C20ml\u002Fmin\u002F1.73m\n4. Active changes in HF therapies over 2 weeks prior to baseline visit\n5. Inability participate in exercise training therapy\n6. Inability to perform CPET (Cardiopulmonary Exercise Testing) testing\n7. Severe left side valvular heart disease\n8. End stage pulmonary disease, requiring continuous supplemental oxygen\n9. Major surgery within 3 months of screening or major elective surgery during the duration of the study.\n10. Unstable weight defined by \\>5% change in body weight in last 30 days before first study visit.\n11. Pregnancy",{"count":222,"type":22},120,[80,112],"Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.\n\nThis study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.",[38,226],"Diabetic Cardiomyopathies",[228,229,230,231],"Diabetic cardiomyopathy","Remote exercise training","Weight loss","Rehab","2025-10-28",{"date":234,"type":60},"2025-10-31",{"date":236,"type":60},"2025-02-18",{"date":238,"type":22},"2026-12-30",{"name":240,"class":98},"University of Texas Southwestern Medical Center",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":17,"sex":18,"minAge":249,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":252,"conditions":253,"keywords":258,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":187},"100609525","us-benchmarking-clinical-study-100609525","NCT07215715","US Benchmarking Clinical Study","Myocardial & Hepatic Shear Wave Velocity Measurements in Patients With Non-Reduced-Ejection Fraction Heart Failure and Control Subjects - US Benchmarking Clinical Study","EMS-CT-1","Inclusion Criteria:\n\nInclusion Criteria Common to all three Study Arms:\n\n1. Male or female age ≥ 60 years\n2. Signed informed consent and able to comply with protocol\n\n   Inclusion Criteria Common to the Heart Failure with non-reduced left ventricular ejection fraction (LVEF) with or without transthyretin amyloid cardiomyopathy (ATTR-CM) Arms:\n3. Patients meeting the Universal Definition of Heart Failure \\& HeartShare study criteria.\n4. LVEF \\>40% on the last available imaging study\n5. Left ventricular hypertrophy (LVH) defined as left ventricular mass index (mass\u002FBSA) in female \\> 95 g\u002Fm², in male \\> 115 g\u002Fm² according to American Society of Echocardiography\u002FEuropean Association of Cariology (ASE\u002FEAC) guidelines42 OR as interventricular septum (IVS) thickness ≥12 mm\n\n   Inclusion criterion specific to HF with non-reduced LVEF without ATTR-CM Arm:\n6. Negative (grade 0) Pyrophosphate (PYP) scintigraphy within 24 months prior to the enrolment in the study OR Simple Score \\\u003C643 OR negative endomyocardial biopsy\n\n   Inclusion criterion specific to HF with non-reduced LVEF with ATTR-CM Arm:\n7. ATTR-CM objectively confirmed and classified at any time prior to the enrollment in the study, with monoclonal protein AL amyloidosis ruled out, according to American Heart Association (AHA) 2020 criteria\n\n   Inclusion criteria in Control Subjects:\n8. No diagnosis of HF or cardiomyopathy according to the universal definition of Heart Failure\n9. No diagnosis of Transthyretin amyloid cardiomyopathy (ATTR-CM) or Amyloid light-chain (AL) amyloidosis\n\nExclusion Criteria:\n\nExclusion criteria common to the three arms:\n\n1. Pregnant OR pre-menopausal woman\n2. Vulnerable patients\n3. Acute Coronary Syndrome within 30 days\n4. Heart rate greater than 130 beats\u002Fminute at the time of the measurements\n5. Atrial fibrillation or flutter at the time of SWV measurement (history of AF is authorized provided they patient is in sinus rhythm at the time of the measurements)\n6. Any clinically significant cardiac arrhythmia at the time of SWV measurement\n7. Poor echogenicity preventing accurate ultrasound measurements\n8. Patients with segmental wall motion abnormalities thought to be due to myocardial infarction.\n9. Severe mitral or aortic valve disease (regurgitation or stenosis) excluded if the cause is other than ATTR (e.g., prolapse, endocarditis, prosthetic valve.)\n10. Severe tricuspid valve disease (regurgitation or stenosis) excluded if the causes are other than ATTR.\n11. Distance from skin to IVS ≥ 8 cm\n12. Any prosthetic mechanical valve\n13. Patients with mechanical cardiac assist devices other than pacemakers or defibrillators\n14. Heart, lung, liver or kidney transplant history or expected in the next year\n15. Severe renal impairment with eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m² or end-stage renal disease or patient on dialysis.\n16. Presence of any competing life-threatening risk over the next 12 months\n17. Complicated uncontrolled diabetes mellitus HbA1c ≥9% with target organ damage.\n18. Uncontrolled and persistent high-blood pressure with diastolic pressure \\> 100 mmHg or systolic pressure \\> 160 mmHg at the time of the measurement.\n19. Acute decompensated state such as volume overload, etc. in the opinion of the study investigator\n20. Skin abnormalities, infections, or open wounds at the site of the SVW measurement\n21. Liver disease, at least moderate\n\n    Exclusion criteria in both the HF with non-reduced LVEF with or without ATTR-CM Arms:\n22. Known inherited cardiomyopathy, infiltrative cardiomyopathy (other than ATTR-CM for the study arm for ATTR-CM), cardiomyopathy from muscular dystrophies, cardiomyopathy with reversible causes (e.g., stress cardiomyopathy), hypertrophic cardiomyopathy or known pericardial constriction\n23. History of treatment for ATTR-CM with Transthyretin (TTR) depleters\n\n    Exclusion criteria Specific to Control Subjects:\n24. Any diagnosis of cardiomyopathy or HF, whatever the cause46\n25. LVH based on LV mass index female \\>95 g\u002Fm², in male ≥115 g\u002Fm² OR IVS thickness ≥12 mm unless thought to be due to athlete's heart","60 Years",{"count":251,"type":22},150,"The goal of this observational study is to measure shear wave velocity (SWV) in patients with non-reduced left ventricular ejection fraction (LVEF) heart failure and left ventricular hypertrophy, with or without transthyretin amyloidosis with cardiomyopathy (ATTR-CM), and in control subjects without heart failure or cardiomyopathy.\n\nThe main question it aims to answer is:\n\n• Can SWV be used to measure myocardial and liver stiffness in the study's target populations? Researchers will compare patients with ATTR-CM, patients without ATTR-CM, and a control group to determine the distributions of SWV in each population.\n\nParticipants will:\n\n* Have a standard cardiology assessment, including a physical exam, blood work, and an echocardiogram.\n* Undergo an investigational assessment with the eMyosound LYRA device to measure SWV in their myocardium and liver.\n* Have the investigational assessment repeated by a second observer to assess measurement reliability.",[38,254,255,256,257],"HFmrEF","ATTR-CM (Transthyretin Amyloid Cardiomyopathy)","Left Ventricular Hypertrophy","Cardiac Amyloidosis",[259,260,245,31,257,261],"Shear Wave Velocity","non-invasive ultrasound elastography","ATTR-CM","2025-10-16",{"date":264,"type":60},"2025-10-20",{"date":266,"type":60},"2025-09-16",{"date":268,"type":22},"2026-07",{"name":270,"class":67},"eMyosound SAS",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":78,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":99},"100567577","move-hf-motivating-physical-activity-with-behavioral-economics-in-heart-failure-with-preserved-ejection-fraction-100567577","NCT06670001","MOVE-HF MOtivating Physical Activity With BehaVioral Economics in Heart Failure With Preserved Ejection Fraction","MOtivating Physical Activity With BehaVioral Economics in Heart Failure With Preserved Ejection Fraction (MOVE-HF)","Inclusion Criteria:\n\nAdults (age ≥ 18 years) who: 1) have a diagnosis of heart failure with preserved ejection; 2) have an ejection fraction ≥ 50%; 3) meet ONE of the following criteria: any history of hospitalization with a primary diagnosis of heart failure with preserved ejection fraction, BNP \\> 75 pg\u002FmL (\\> 225 pg\u002FmL in patients with atrial fibrillation), H2FPEF score ≥ 5, OR elevated pulmonary capillary wedge pressure on right heart catheterization (≥ 15 mm Hg at rest or ≥ 25 mm Hg with exercise); 4) own a smartphone or tablet capable of connecting to the internet; 5) are able to read English; 6) are able to provide informed consent\n\nExclusion Criteria:\n\nParticipants will be excluded if they are currently participating in another interventional physical activity study, have medical conditions prohibiting ambulation without assistance (including use of an assistive device other than a cane) or participation in an exercise program, if a 9-month physical activity program is infeasible or unsafe, upcoming cardiovascular procedures (e.g. stent or surgery) or if the patient is at a high level of physical activity (\\>7500 steps per day) or very low level of physical activity (\\\u003C 1000 steps\u002Fday) at baseline. Patients taking \\> 7500 steps\u002Fday will be excluded based on data showing that increasing step count beyond 7500 steps\u002Fday does not improve outcomes in all-comer populations, and to ensure that we are recruiting a population of patients with symptomatic HF. Patients taking \\\u003C 1000 steps\u002Fday at baseline will be excluded to ensure that we will not enroll very frail patients with a need for more intensive exercise training or physical therapy. To ensure that we are capturing patients who are limited in their exertional capacity by heart failure, we will also exclude patients with dementia, end-stage renal disease on dialysis, cirrhosis, cardiac surgery or transcatheter valve replacement within the last year, severe aortic stenosis or severe mitral stenosis.",{"count":279,"type":22},270,[143],"This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or competition - to increase adherence to physical activity among individuals with HFpEF. There will be a 2-week run-in period to obtain baseline measures of physical activity, followed by a 6-month intervention period and then a 3-month follow-up period.",[38],"2025-09-17",{"date":285,"type":60},"2025-09-22",{"date":287,"type":60},"2025-06-05",{"date":289,"type":22},"2029-03-31",{"name":291,"class":98},"University of Pennsylvania",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":99},"100575571","heart-failure-in-patients-with-diabetes-cells-crosstalk-and-consequences-100575571","NCT06774014","Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences","Inclusion Criteria:\n\n* Age \\>18 years\n* Ability to provide written informed consent\n* Persons who are legally competent and mentally able to follow the instructions of the study staff\n\nExclusion Criteria:\n\n* Anaemia Hb \\\u003C8 mg\u002Fdl\n* Patients with acute infectious diseases (e.g. pneumonia)\n* Patients with heart failure due to sepsis\n* People with acute myocardial ischemia, which is manifested, for example, by angina pectoris or ECG changes under stress\n* Patients with acute liver or kidney failure or severe COPD (FEV1\\\u003C1.0)\n* Pregnant and breastfeeding women\n* People who are institutionalized on official or court orders\n* People who are dependent or employed by the sponsor or investigator\n* Taking study medication (of an investigational drug) 30 days before the start of the study",{"count":299,"type":22},600,"This will be an observational study to explore differences in pathophysiology between groups of people with and without heart failure (HF) (reduced and preserved ejection fraction) and with and without diabetes mellitus (DM) with a particular focus on cross-talk (fat, muscle, vascular tissue and the heart). The investigators will invite 600 people to partcipate (100 with HFrEF+DM, 100 with HFpEF+DM, 100 with HFpEF-DM, 100 with HFrEF-DM, 100 with DM, 100 without either HR or DM). Special heart scans, exercise testing, blood testing, testing of the automatic nervous system will be performed and in some, samples of fat and muscle and endothelial cells will be collected.\n\nThese data will be used to create a cohort of well phenotyped patients with a variety of comprehensively collected clinical information, a cell atlas, and a comprehensive assessment of metabolomics, proeomics and cross-talk in between tissues, allowing comparisons between each group.",[302,31,37,38],"Diabetes Mellitus Type 2",[304,305,306,307,308,309,310,311],"Crosstalk","Metabolomics","Proteomics","Fat","Skeletal muscle","Vascular function","Autonomic function","Endothelial function","2025-02-27",{"date":314,"type":60},"2025-02-28",{"date":316,"type":60},"2025-02-26",{"date":318,"type":22},"2030-01-31",{"name":320,"class":98},"University of Leeds",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":78,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":99},"100572997","atrial-fibrillation-with-heart-failure-with-preserved-ejection-fraction-treatment-strategies-catheter-ablation-vs-anti-atrial-arrhythmia-drugs-100572997","NCT06740539","Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs","Inclusion Criteria:\n\n* Age ≥18 years.\n* The patient is willing and able to comply with the protocol and has provided written informed consent.\n* Paroxysmal or persistent atrial fibrillation (AF).（Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than seven days but necessitating pharmacologic or electric cardioversion. Included within the category of persistent AF is 'long-standing persistent AF', defined as continuous AF of \\>1-year duration. AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter ECG, Loop Recorder, memory of the implanted device (ICD\u002FCRT-D), or any other suitable device.）\n* Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs.\n* Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).（(1) a history of hospitalization for HF with symptoms classified as New York Heart Association (NYHA) class II, III, or IV; (2) LVEF ≥ 50%; (3) at least one of the following cardiac structural abnormalities identified by echocardiography: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevated levels of N-terminal pro-brain natriuretic peptide (NT-proBNP), with a threshold of ≥400 pg\u002FmL for pa-tients with SR at admission and ≥600 pg\u002FmL for patients with AF at admis-sion.)\n* New York Heart Association class II, III, or IV.\n\nExclusion Criteria:\n\n* Previous left heart ablation procedure for AF.\n* Contraindication to chronic anticoagulation therapy or heparin.\n* Documented left atrial diameter \\>6 cm, optimally from the parasternal long-axis view.\n* Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.\n* Planned cardiovascular intervention.\n* Listed for heart transplant.\n* Cardiac assist device implanted.\n* Life expectancy ≤ 12 months.\n* Mental or physical inability to participate in the study.\n* Requirement for dialysis due to terminal renal failure.\n* Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age.\n* Enrollment in another investigational drug or device study, or participation in another telemonitoring concept.",{"count":328,"type":22},304,[143],"A comparison of whether catheter ablation improves the prognosis (all-cause mortality and\u002For the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). This trial was randomly divided into two groups: the anti-AAD drug group and the catheter ablation group.",[332,333],"HFpEF - Heart Failure with Preserved Ejection Fraction","Atrial Fibrillation (AF)","2024-12-15",{"date":336,"type":60},"2024-12-18",{"date":338,"type":22},"2024-12-16",{"date":340,"type":22},"2027-01-01",{"name":342,"class":98},"Shanghai Chest Hospital",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":353,"conditions":354,"keywords":355,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":99},"100555648","exercise-magnetic-resonance-imaging-in-patients-with-obesity-associated-heart-failure-100555648","NCT06514820","Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure","EXercise Magnetic Resonance Imaging in Patients With Obesity aSsociated Heart failURe With Preserved Ejection Fraction (EXPOSURE) Study","EXPOSURE","Inclusion Criteria:\n\n1. Signs and symptoms of HF according to the Europeans Society of Cardiology guideline.\n2. LV ejection fraction ≥40%.\n3. HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test (Figure 1).\n4. \\>18 years of age\n5. In sinus rhythm\n6. Able to perform a bicycle exercise test\n7. Willing to sign informed consent\n\nExclusion Criteria:\n\n1. Body weight \\>140 kg\n2. Atrial fibrillation or other significant arrhythmia during the assessment\n3. Contraindications for CMR (e.g. claustrophobia, implanted cardiac devices)\n4. Myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft \\\u003C3 months or untreated severe obstructive coronary artery stenosis\n5. More than moderate left-sided valve disease.\n6. Complex congenital heart disease.",{"count":352,"type":22},50,"To aim of the EXPOSURE study is to investigate the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing in patients with HFpEF.",[38],[356,87,357],"Epicardial fat","Exercise MRI","2024-07-16",{"date":360,"type":60},"2024-07-23",{"date":362,"type":60},"2024-01-16",{"date":364,"type":22},"2025-12-31",{"name":366,"class":98},"University Medical Center Groningen",{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":78,"phases":377,"briefSummary":378,"conditions":379,"keywords":380,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":99},"100525760","catheter-ablation-in-atrial-fibrillation-patients-with-hfpef-stable-sr-iv-trial-100525760","NCT06125925","Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)","Catheter Ablation in Atrial Fibrillation Patients With Heart Failure With Preserved Ejection Fraction: an International, Prospective, Multi-center, Randomized Controlled Study (STABLE-SR IV Trial)","Inclusion Criteria:\n\n* Symptomatic paroxysmal or persistent atrial fibrillation\n* CHADS2-VASc score≥ 2\n* Conform to the diagnosis of HFpEF\n\n  1. NYHA II-IV level;\n  2. Left ventricular ejection fraction (LVEF)≥ 50%;\n  3. NT-proBNP≥ 300 pg\u002FmL under sinus rhythm or NT-proBNP≥ 600 pg\u002FmL under atrial fibrillation or flutter;\n  4. Evidence of left ventricular diastolic dysfunction\u002Fraised left ventricular filling pressure on echocardiogram.\n* Sign informed consent\n\nExclusion Criteria:\n\n* A life expectancy below 2 years due to any non-cardiovascular condition\n* Reversible atrial fibrillation, such as hyperthyroidism or hypokalemia-related atrial fibrillation\n* Prior atrial fibrillation ablation\n* Left atrial size≥ 55 mm\n* Heart failure due to any of the following: known genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease\n* Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease\n* Any contraindication for radiofrequency catheter ablation, antiarrhythmic drugs or anticoagulation\n* Acute coronary syndrome, cardiac surgery, angioplasty or cerebrovascular accident within 12 weeks before enrollment\n* Severe hepatic and renal dysfunction\n* Body mass index\\> 50 kg\u002Fm2\n* Female in period of pregnancy or breast-feeding\n* Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study\n* Involved in other studies\n\nThe inclusion and exclusion criteria would be reassessed after run-in period and the cut-off of NT-proBNP would be set as \\>125 pg\u002Fml under sinus rhythm or \\>365 pg\u002Fml under AF\u002Fatrial flutter (AFL).","80 Years",{"count":376,"type":22},436,[143],"To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.",[201,38],[381,87,382,383],"atrial fibrillation","radiofrequency catheter ablation","drug therapy","2023-12-05",{"date":386,"type":60},"2023-12-11",{"date":388,"type":60},"2023-11-06",{"date":390,"type":22},"2026-11",{"name":392,"class":98},"The First Affiliated Hospital with Nanjing Medical University"]