[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hfref---heart-failure-with-reduced-ejection-fraction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hfref---heart-failure-with-reduced-ejection-fraction":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,71,96,150,191,217,258,286,308,330],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100624556","wearable-device-assisted-remote-management-in-atrial-fibrillation-complicated-by-heart-failure-warm-hf-trial-100624556",false,"NCT07411170","Wearable Device-Assisted Remote Management in Atrial Fibrillation Complicated by Heart Failure: WARM-HF Trial","Wearable Device-assisted Remote Management for Patients With Atrial Fibrillation Complicated by Heart Failure: A Prospective, Open-label, Multi-center, Randomized Controlled Trial","WARM-HF","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Subjects diagnosed with acute decompensated heart failure (ADHF) :1)Heart failure with reduced ejection fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 40%;2)New York Heart Association (NYHA) functional class II-IV;3)NT-proBNP \\> 2500 pg\u002FmL or BNP \\> 600 pg\u002FmL\n3. Atrial fibrillation (AF) diagnosed during hospitalization (documented AF episode lasting \\> 30 seconds on electrocardiogram \\[ECG\\] within the past 12 months)\n\nExclusion Criteria:\n\n1. Intolerance to heart failure pharmacotherapy\n2. Severe anemia, uncorrected thyroid disease\n3. ST-segment elevation myocardial infarction (STEMI) within 3 months\n4. Known complex congenital\u002Fsecondary heart disease; infiltrative cardiomyopathy (e.g., cardiac amyloidosis, sarcoidosis, lymphoma, or endomyocardial fibrosis); myocarditis; constrictive pericarditis; cardiac tamponade; hypertrophic cardiomyopathy; stress cardiomyopathy (Takotsubo cardiomyopathy); or uncorrected primary valvular heart disease requiring surgical intervention.\n5. Previous or planned major cardiac surgery or mechanical circulatory support within 6 months, including coronary artery bypass grafting, cardiac valve repair or replacement, ventricular assist device or mechanical circulatory support device implantation, and heart transplantation.\n6. Current use of or planned implantation of a pacemaker.\n7. Contraindications to wearing a smartwatch (e.g., limb disability or known allergy to rubber\u002Fmetal materials)\n8. Inability to access the Internet or lack of proficiency in operating smart devices\n9. Pregnant or lactating women\n10. Organ transplantation within the past 12 months\n11. Expected survival time of less than 1 year for any reason\n12. Refusal to participate or inability to comply with follow-up requirements\n13. Deemed ineligible for participation in the study by the investigators","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","INTERVENTIONAL",[24],"NA","Patients with acute decompensated heart failure (HF) have a significantly high risk of death and HF re-hospitalization during the vulnerable phase post discharge. Therefore, early post-discharge management is crucial, and the cornerstone of HF treatment-particularly for HF with reduced ejection fraction (HFrEF)-is guideline-directed medical therapy (GDMT), a comprehensive pharmacotherapeutic strategy supported by robust clinical evidence. Timely titration of GDMT, especially within the first few weeks after discharge, has been shown to improve clinical outcomes, reduce readmissions, and enhance long-term prognosis. However, ensuring optimal follow-up and therapeutic adjustments remains a major challenge in real-world practice. Atrial fibrillation (AF) is a common comorbidity in patients with HF, especially in those with severe HF. The presence of AF significantly complicates the clinical course and worsens the prognosis of HF.\n\nAdvances in wearable technology have made continuous, non-invasive monitoring of vital signs, arrhythmia burden, and physical status increasingly feasible. Devices such as smartwatches and ECG belts can provide real-time physiological data, offering new opportunities for remote and proactive disease management. Despite the growing availability of such data, the complex interplay between AF and HF demands highly personalized management. Currently, there is a lack of high-quality clinical evidence on how to effectively integrate wearable device data into personalized strategies for this specific patient population.\n\nThis is an open-label, multi-center, endpoint-blinded, parallel-group randomized clinical trial supported by the American Heart Association. The primary objective is to determine whether wearable device-assisted digital consultations can optimize GDMT in patients with AF complicated by acute decompensated HF. The study plans to enroll 400 participants, who will be randomly assigned to either a wearable device-assisted intervention group or a conventional treatment control group. The primary endpoint is the change in HF GDMT score 3 months after randomization.\n\nApple Inc. provided funding, devices, and technical support for this study. Apple was not a sponsor of the trial and was not involved in its execution, data analysis, interpretation, or manuscript preparation.",[27,28],"HFrEF - Heart Failure With Reduced Ejection Fraction","AF - Atrial Fibrillation","NOT_YET_RECRUITING","2026-06-25",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":21},"2026-08",{"date":37,"type":21},"2028-09",{"name":39,"class":40},"Beijing Anzhen Hospital","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100618737","impact-of-barostimulation-on-hemodynamics-in-adults-with-heart-failure-100618737","NCT07335510","Impact of Barostimulation on Hemodynamics in Adults With Heart Failure","Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device","BREATHE-HF","Inclusion Criteria:\n\n* Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)\n* Symptoms consistent with one of:\n\n  1. current New York Heart Association (NYHA) Class III or\n  2. current NYHA Class II and historical NYHA Class III\n* Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\\u003C 1600 pg\u002Fml (should be within 3 months of screen)\n* Management with maximally-tolerated GDMT medications and devices\n* Age \\>= 18 years\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening\n* Bilateral carotid bifurcations located above the level of the mandible\n* Carotid artery stenosis greater than 50% caused by atherosclerosis\n* Ulcerative plaques in the carotid artery\n* Baroreflex failure or autonomic neuropathy\n* Symptomatic un-controlled bradyarrhythmias\n* Severe chronic lung disease\n* Current treatment with inotropes\n* Pacemaker or ICD within 3 months of screening\n* Cardiac resynchronization therapy (CRT) devices within 6 months of screening or anticipated to be placed in the next 90 days following screening\n* Prior surgery, radiation, endovascular stent in the carotid sinus\n* History or consideration of solid organ transplantation\n* History or consideration of left ventricular assist device (LVAD)\n* Life expectancy \\\u003C1 year from time of screening\n* Non-cardiovascular conditions interfering with 6MWT distance assessment\n* Inability to fulfill protocol requirements\n* Known allergy to silicone or titanium",{"count":50,"type":21},58,[24],"This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. The study aims to assess how therapy using this device affects heart function, symptoms, and exercise capacity, with particular focus on how the device affects blood flow and heart pressures during exercise. Information from this study may help inform patient selection and device management in patients with heart failure.",[27],[55,56,57,58,59,60,61],"Baroreflex activation therapy","Exercise hemodynamics","Barostim","Cardiopulmonary exercise testing","Neuromodulation","Functional capacity","Heart failure with reduced ejection fraction","RECRUITING",{"date":32,"type":33},{"date":65,"type":33},"2026-03-30",{"date":67,"type":21},"2028-03",{"name":69,"class":40},"Columbia University",7,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100643764","eccentric-muscle-training-in-cardiac-rehabilitation-100643764","NCT07636343","Eccentric Muscle Training in Cardiac Rehabilitation","Eccentric Muscle Training in Cardiac Rehabilitation: Randomized Controlled Trial to Evaluate Effectiveness and Feasibility in Heart Failure Patients With Reduced Ejection Fraction","Inclusion Criteria:\n\n* HFrEF patients with ejection fraction \\\u003C40%\n* Exercise intolerance (\\\u003C85% of predicted VO2 peak)\n* clinically stable for \\> 6 weeks, optimal medical treatment for \\> 6 weeks\n\nExclusion Criteria:\n\n* Contra indications for cardiac exercise rehabilitation as per consensus guidelines and recommendations\n* Musculoskeletal disorders that hamper (progression in) strength training\n* Non-stabilized acute coronary syndrome\n* Current acute heart failure (decompensation)\n* Patient having sustained a recent (\\\u003C3 months) procedure that could act as a confounder to increase VO2peak (i.e., coronary artery bypass graft surgery, percutaneous coronary intervention, cardiac resynchronization therapy, valve surgery or reparation)",{"count":79,"type":21},3,[24],"The goal of this interventional study is to assess the training effects in a training schedule in which eccentric overload training and eccentric cycle training are used.\n\nResearchers will compare a training program of eccentric overload training and eccentric cycling training with a traditional training program of strength and cardio training in people with heart failure with reduced ejection fraction.\n\nThis study will be delivered in a cardiac rehabilitation setting.",[83,27],"Strength Training Effects",[85],"eccentric muscle training","2026-06-03",{"date":88,"type":33},"2026-06-09",{"date":90,"type":33},"2023-01-20",{"date":92,"type":21},"2027-01-01",{"name":94,"class":40},"University Hospital, Antwerp",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":124,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":149},"100569808","ai-enabled-direct-from-ecg-ejection-fraction-ef-severity-assessment-using-cor-ecg-wearable-monitor-100569808","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,{"count":106,"type":21},2000,"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.",[110,111,112,113,114,115,116,117,118,119,120,27,121,122,123],"Ventricular Ejection Fraction","LVF","LV Dysfunction","Atrial Enlargement","Conduction Defect","Heart Failure","Valvular Heart Disease","Ischemic Heart Disease","Cardiotoxicity","Myocardial Infarction","Dilated Cardiomyopathy","HFpEF - Heart Failure With Preserved Ejection Fraction","Syncope","Remodeling, Cardiac",[125,126,127,128,129,130,131,112,132,133,134,135,136,137,113,138],"ECG Patch","LVEF","Holter","ECG Wearable","COR","Atrial Conduction","ECG Biomarker","SaMD","Clinical Decision Support","ECG","EF Severity","Ejection Fraction","AI","Electrical Remodeling","2026-05-28",{"date":141,"type":33},"2026-06-01",{"date":143,"type":33},"2024-11-21",{"date":145,"type":21},"2027-11-15",{"name":147,"class":148},"Peerbridge Health, Inc","INDUSTRY",8,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":95},"100595211","phase-2-swedish-cardiac-and-renal-failure-study-1-100595211","NCT07029503","Swedish Cardiac And Renal Failure Study-1","Swedish Cardiac And Renal Failure Study-1 (SCARF-1): An Open-Label Pilot Trial to Evaluate the Feasibility, Safety and Efficacy of Eplerenone in Patients With Heart Failure With Reduced Ejection Fraction and Severe Chronic Kidney Disease","SCARF-1","Inclusion Criteria:\n\n* The participant has given their written consent to participate\n* A diagnosis of HFrEF according to current criteria, for at least three months before the screening visit\n* Echocardiography within 24 months of the screening visit with ejection fraction ≤ 40%. The responsible investigator is allowed to order a new TTE at their own discretion if clinically indicated - e.g. following the initiation of markedly intensified HFrEF-treatment or in the event of significant clinical deterioration. If the new TTE shows an EF \\> 40%, the participant will not be eligible for inclusion. However, a potential echocardiographic worsening should not, by itself, preclude enrollment\n* New York Heart Association class II-III\n* Optimally treated and stable HFrEF (according to the investigator) since at least four weeks before the screening visit. Treatment should include beta-blockers, sodium\u002Fglucose co-transporter 2 inhibitors, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers if eGFR ≥ 20 ml\u002Fmin\u002F1.73m2 according to the revised Lund-Malmö method. Participants should also have cardiac resynchronization therapy or an implantable cardioverter-defibrillator if the indication exists according to current guidelines\n* eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2 according to the revised Lund-Malmö method at least once during the 12 months before the screening visit, and eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m2 at the time of inclusion\n\nExclusion Criteria:\n\n* P-K ≥ 5.6\n* For the first ten study participants:\n\neGFR \\\u003C 20 ml\u002Fmin\u002F1.73m2 according to the revised Lund-Malmö method, or projected decline in eGFR to \\\u003C 10 ml\u002Fmin\u002F1.73m2 during the 36-week study period. The projected decline will be estimated using the three most recent eGFR values from the previous 6-12 months\n\n\\- For the remainder of the study participants: eGFR \\\u003C 10 ml\u002Fmin\u002F1.73m2 according to the revised Lund-Malmö method, or projected decline in eGFR to \\\u003C 10 ml\u002Fmin\u002F1.73m2 during the 36-week study period. The projected decline will be estimated using the three most recent eGFR values from the previous 6-12 months\n\n* Ongoing\u002Fplanned dialysis\n* Systolic blood pressure \\\u003C 90 mmHg\n* Uncontrolled hypertension as judged by the investigator\n* Severe hepatic impairment (Child-Pugh C)\n* History of, or planned, heart transplantation or left ventricular assist device\n* Unwillingness to comply with highly effective contraceptive methods, or ongoing\u002Fplanned pregnancy, or breastfeeding\n* Previous allergic reaction to an MRA or a potassium binder\n* Ongoing treatment with lithium, cyclosporine, tacrolimus, nonsteroidal anti-inflammatory drugs, trimethoprim, or strong CYP3A inhibitors (ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin, and nefazodone) or inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's Wort)\n* QTc(f) ≥ 550 msec, history of QT prolongation associated with any medication requiring medication discontinuation, or congenital long QT syndrome\n* Uncontrolled arrhythmia as judged by the investigator\n* Acute cardiac hospitalization or procedure within four weeks before inclusion\n* Not suitable as judged by the investigator (presumed inability to participate, severe or terminal co-morbidity, and expected survival \\\u003C 12 months)\n* Previously enrolled in this trial or participation in another trial not approved for co-enrollment",{"count":159,"type":21},40,[161],"PHASE2","Previous studies have shown that patients with heart failure with reduced pumping function and preserved kidney function experience improved symptoms, longer survival, and fewer hospitalizations when treated with medications such as eplerenone. However, individuals with impaired kidney function have been excluded from these trials due to concerns about potential adverse effects on potassium levels, kidney function, and possibly also blood pressure. As a result, clear treatment recommendations for this high-risk group are lacking.\n\nIn recent years, however, background therapies have been modernized and are now associated with a lower risk of potassium disturbances. Preliminary data also suggest that patients with impaired kidney function may benefit from eplerenone treatment. However, confirmation through dedicated studies is needed.\n\nThe primary objective of this pilot trial is to assess the feasibility and safety of eplerenone in patients with heart failure with reduced pumping function and impaired kidney function. Treatment effectiveness will also be explored.",[27,164],"Chronic Kidney Disease",[166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181],"HFrEF - Heart Failure with Reduced Ejection Fraction","Chronic kidney disease","Heart failure","Chronic heart failure","HFrEF","CKD","Renal dysfunction","Kidney dysfunction","Renal impairment","Advanced","Severe","Mineralocorticoid receptor antagonists","MRA","Eplerenone","Sodium Zirconium Cyclosilicate","SZC","2026-02-21",{"date":184,"type":33},"2026-02-24",{"date":186,"type":21},"2026-02",{"date":188,"type":21},"2027-10",{"name":190,"class":40},"Karolinska Institutet",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":95},"100103452","phase-3-alp-1-continuous-intravenous-infusion-to-maintain-clinical-stability-in-advanced-heart-failure-100103452","NCT00610051","ALP-1 Continuous Intravenous Infusion to Maintain Clinical Stability in Advanced Heart Failure","Phase 3 Study of Alprostadil Continuous Intravenous Infusion to Maintain Clinical Stability in Severe Heart Failure Patients","1. Patients older than 18 years of age, of any gender\u002Fsex and race\u002Fethnicity\n2. Patients with a diagnosis of advanced HFrEF as evidenced by (all must apply):\n\n   1. most recent LVEF( by conventional imaging method\\\u003C30% which was mwasured within 3 months prior randomization.\n   2. Nt-proBNP \\>1500 ng\u002FL or BNP \\>300 ng\u002FL at prior randomization\n   3. New York Heart Association (NYHA) functional class IIIb or IV, i.e., chronic dyspnoea or fatigue at rest or with minimal exertion for at least one month prior to consent.\n   4. Renal dysfunction reflected by a glomerular filtration rate (GFR) \\\u003C60 mL\u002Fmin approximated by the Modification of Diet in Renal Disease formula.\n   5. A total symptom score of KCCQ of \\\u003C70measure within 24 hours of randomization\n   6. Patients on all appropriate recommended HF therapy.\n3. Patient should not be receiving continuous or planned intermittent intravenous infusions with a positive inotropic or vasodilator drug in a non-hospitalized setting\n4. Patients should not be considered as candidates for heart transplantation or LVAD for at least 6 months from randomization according to the opinion of the treating physician.\n5. Women of childbearing potential (i.e., who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must commit either to abstain continuously from heterosexual sexual contact or to use at least one \"highly effective\" method of birth control (e.g., intrauterine device \\[IUD\\], hormonal contraception, tubal ligation, or partner's vasectomy) or two \"effective\" methods (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to screening and throughout study participation.\n\n   Note: As alprostadil is not genotoxic and female sexual partners of male study participants are not likely to have substantial exposure via semen, there are no contraception requirements for men.\n6. Patients must be willing and able to give written informed consent, including local data privacy consents, as required",{"count":199,"type":21},600,[201],"PHASE3","This is a global multicenter, doubleblind, placebo-controlled, randomized, parallel-group study that compares ALP-1 given in a continuous infusion ( compared to placebo), 250mcg\u002Fday on majore outcomes up to 6 months after randomization in participants with advanced HF with reduced ejection fraction(HFrEF).",[204,27,205],"End Stage Cardiac Failure","NYHF Class III-IV",[207],"advanced HFrEF","2025-12-12",{"date":210,"type":33},"2025-12-15",{"date":212,"type":21},"2026-10",{"date":214,"type":21},"2030-12",{"name":216,"class":148},"Biopeutics Co., Ltd",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":225,"maxAge":226,"enrollmentInfo":227,"targetDuration":229,"studyType":107,"phases":4,"briefSummary":230,"conditions":231,"keywords":237,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":95},"100605622","predictive-factors-of-response-to-phase-ii-cardiac-rehabilitation-in-heart-failure-with-reduced-ejection-fraction-100605622","NCT07164911","Predictive Factors of Response to Phase II Cardiac Rehabilitation in Heart Failure With Reduced Ejection Fraction","Prédiction Des réponses du Patient Porteur d'Une Insuffisance Cardiaque à Fraction d'éjection altérée à Une Phase II de réadaptation Cardiaque","PrédicRéa","Inclusion Criteria:\n\n* Heart failure with reduced ejection fraction \\\u003C 40%\n* NYHA functional class ≥ II\n* Clinically stable for at least 6 weeks\n* On optimized medical therapy for at least 6 weeks\n* Prescription for phase II cardiac rehabilitation\n* BMI between 20-30 kg·m-²\n* Physical activity level: sedentary or physically active but untrained\n* Signed informed consent to participate in the study\n* Affiliation to the French national health insurance system\n\nExclusion Criteria:\n\n* Contraindication to regular adapted physical activity\n* Uncontrolled arterial hypertension\n* Secondary respiratory disease such as emphysema or chronic obstructive pulmonary disease (COPD)\n* Secondary cardiovascular disease\n* Individuals under legal protection or deprived of liberty\n* Pregnant or breastfeeding women","40 Years","75 Years",{"count":228,"type":21},62,"1 Month","Exercise intolerance, measured as peak oxygen consumption (VO₂peak) during exercise in patients with heart failure with reduced ejection fraction (HFrEF). Change in VO₂peak (ΔVO₂peak), which serves as a prognostic marker for HFrEF engaged in exercise based cardiac rehabilitation program (ExCR). Responders to ExCR generally show improved cardiac function but some patients with HFrEF do not respond to ExCR. VO₂peak depends on three major components of oxygen transport: Pulmonary (lungs), circulatory (heart and vessels) and skeletal muscle (oxygen utilization) functions. These physiological responses to ExCR may be influenced by epigenetic regulation, specifically the expression of circulating microRNAs (c-miRNAs).\n\nLinking non-invasive measurements and epigenetic markers could 1) identify which component of the oxygen transport chain is most impaired and 2) allow personalized interventions to maximize VO₂peak improvements.\n\nThe primary objective of this stidy is to assess the association between changes in VO₂peak during exercise training and circulating microRNA expression (miR-146a, miR-191, miR-23a, miR-140, miR-1, miR-21, miR-133a, miR-17-5p, miR-3200-3p).\n\nThe secondary objective is to examine the relationship between pulmonary, cardiovascular, and neuromuscular adaptations to exercise and circulating microRNA expression.",[27,232,233,234,235,236],"Cardiac Rehabilitation","Exercise Training","Exercise Adaptations","Exercise Intolerance","Exercise Intervention",[238,239,240,241,242,243,244,245,246,247],"Exercise-based cardiac rehabilitation in patients with reduced left ventricular ejection fraction","VO2peak","MicroRNA","Muscle Oxygenation","arterial stiffness","cardiac output","stroke volume","Oxygen alveolar-arterial gradient","alveolar ventilation","minute ventilation","2025-12-08",{"date":250,"type":33},"2025-12-16",{"date":252,"type":33},"2025-11-25",{"date":254,"type":21},"2027-11-30",{"name":256,"class":257},"Centre Hospitalier de Corbie","OTHER_GOV",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":104,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":95},"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":199,"type":21},"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.",[267,115,27,121],"Diabetes Mellitus Type 2",[269,270,271,272,273,274,275,276],"Crosstalk","Metabolomics","Proteomics","Fat","Skeletal muscle","Vascular function","Autonomic function","Endothelial function","2025-02-27",{"date":279,"type":33},"2025-02-28",{"date":281,"type":33},"2025-02-26",{"date":283,"type":21},"2030-01-31",{"name":285,"class":40},"University of Leeds",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":4},"100516274","vsling-iii-clinical-evaluation-of-the-vsling-device-for-ventricular-repair-in-patients-with-heart-failure-100516274","NCT06002386","Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients with Heart Failure","Vsling III","Inclusion Criteria:\n\n1. Age≥ 18 and \\\u003C 85 years\n2. Left ventricular end diastolic diameter is greater than or equal to 55mm\n3. Ejection fraction ≥20% and ≤40%\n4. FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography (via a transthoracic or transesophageal echo)\n5. End-systolic Interpapillary muscle distance ≥ 20mm\n6. NYHA class II-IVa\n7. Cardiomyopathy of ischemic or non-ischemic origins\n8. Understands the nature of the study and procedure and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Any evidence of structural (chordal or leaflet) mitral lesions\n2. Ventricular tachycardia or ventricular fibrillation within 6 months prior to inclusion in this study\n3. Prior mitral valve repair or replacement\n4. ICD\u002FCRT\u002Fcardiac pacemaker leads implanted within 3 months prior to inclusion in this study\n5. Clinical signs of cardiogenic shock within 30 days prior to inclusion in this study\n6. Anatomy that, in the opinion of the interventionalist, prevents safe passage of the Vsling™ catheter(s).\n7. Severe aortic stenosis\n8. Severe, massive, or torrential tricuspid regurgitation requiring surgical or transcatheter repair\n9. Known fixed pulmonary hypertension with PA systolic pressure \\>70 mmHg not responsive to vasodilator therapy\n10. ST segment elevation myocardial infarction within 30 days prior to inclusion in this study\n11. Congenital heart disease (except PFO, PDA or ASD)\n12. Heart Failure due to confirmed amyloid or other restrictive cardiomyopathies\n13. Chronic renal insufficiency defined by Creatinine ≥ 3.0 mg\u002FdL or chronic renal replacement therapy\n14. Any therapeutic invasive cardiac procedure within 30 days prior to inclusion in the study\n15. Any cardiac surgery, within 3 months prior to inclusion in the study\n16. Cerebrovascular Accident (CVA) within 90 days prior to inclusion in this study\n17. Thrombocytopenia (Platelet count\\\u003C 100,000\u002Fmm3) or thrombocytosis (Platelet count \\> 750,000\u002Fmm3)\n18. Body temperature \\>38°C within 3 days prior to index procedure\n19. Bleeding disorders or hypercoagulable state\n20. Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant\n21. Contraindication to anticoagulants or antiplatelet agents\n22. Known allergy to stainless steel, nickel, titanium or contrast agents that cannot be adequately pre-medicated\n23. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically\n24. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study\n25. Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to \\\u003C 12 months\n26. Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study\n27. Pregnancy","85 Years",{"count":295,"type":21},10,[24],"Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated with ventricular dilation.",[166],"2025-01-01",{"date":301,"type":33},"2025-01-03",{"date":303,"type":21},"2025-08",{"date":305,"type":21},"2029-12",{"name":307,"class":148},"Cardiac Success",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":170,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":326,"leadSponsor":328,"locationsCount":79},"100571204","vericiguat-for-heart-failure-with-reduced-ejection-fraction-after-myocardial-infarction-100571204","NCT06717204","Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction","Vericiguat for Ventricular Remodeling in Patients With Heart Failure With Reduced Ejection Fraction After Myocardial Infarction","Inclusion Criteria:\n\n1. The history of acute myocardial infarction exceeds 3 months;\n2. Symptoms and signs of heart failure have been stable for more than one month;\n3. 18 years old or more;\n4. NYHA cardiac function classified as grade II\\~IV;\n5. LVEF≤40%；\n6. NT-proBNP≥450pg\u002Fml；\n7. All subjects or their guardians must sign the subject consent before entering the trial.\n\nExclusion Criteria:\n\n1. Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;\n2. Mechanical complications of myocardial infarction;\n3. Unable to obtain primary outcome data.",{"count":316,"type":21},210,"The effects of vericiguat on cardiac remodeling in patients with chronic stable heart failure after myocardial infarction have not been reported. This project aims to clarify the efficacy and safety of vericiguat in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure with reduced ejection fraction after myocardial infarction in the electronic medical records of Qilu Hospital of Shandong University will be selected and divided into two groups: the treatment group received vericiguat in addition to conventional treatment and the control group received conventional treatment only. After 12-month treatment, the effects of vericiguat on cardiac remodeling and function and cardiovascular adverse events will be evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure after myocardial infarction.",[27,319],"Myocardial Infarction (MI)",[170,119,321],"Vericiguat","2024-12-01",{"date":324,"type":33},"2024-12-04",{"date":299,"type":21},{"date":327,"type":21},"2027-12-31",{"name":329,"class":40},"Qilu Hospital of Shandong University",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":338,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":356},"100416528","phase-1-modulation-of-serca2a-of-intra-myocytic-calcium-trafficking-in-heart-failure-with-reduced-ejection-fraction-100416528","NCT04703842","Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction","A Phase 1\u002F2 Trial of the Safety and Efficacy of SRD-001 (AAV1\u002FSERCA2a) in Subjects With Heart Failure With Reduced Ejection Fraction","MUSIC-HFrEF1","Main Inclusion Criteria:\n\n* Chronic ischemic or non-ischemic cardiomyopathy\n* NYHA class III\u002FIV\n* LVEF ≤35%\n* Guideline-directed medical therapy for heart failure; ICD\n\nMain Exclusion Criteria:\n\n* Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm\n* Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), mechanical circulatory support device (MCSD) or cardiac shunt\n* Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment\n* Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability\n* Inadequate hepatic and renal function\n* Diagnosis of, or treatment for, any cancer within the last 5 years except for basal cell carcinoma or carcinomas in situ where surgical excision was considered curative","80 Years",{"count":340,"type":21},57,[342,161],"PHASE1","It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.",[345,346,115,27],"Congestive Heart Failure","Heart Failure, Systolic","2024-03-24",{"date":349,"type":33},"2024-03-26",{"date":351,"type":33},"2021-09-23",{"date":353,"type":21},"2028-12",{"name":355,"class":148},"Sardocor Corp.",5]