[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-with-reduced-ejection-fraction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-with-reduced-ejection-fraction":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,60,0,25,[9,47,78,110,140,163,195,219,248,276,303,329,349,374,396,426,451,484,507,537,560,587,611,644,668],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053271","implementation-and-interaction-of-clinician-and-patient-facing-tools-aiming-to-intensify-neurohormonal-medicines-for-heart-failure-100053271",false,"NCT06526988","Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure","Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure With Reduced Ejection Fraction: I-I-CAPTAIN-HF","IICAPTAIN-HF","Inclusion Criteria:\n\nClinician:\n\n* Clinician (MD, PA, NP) who practices in cardiology outpatient clinics\n* Regularly sees patients with left ventricular ejection fraction (EF) \\\u003C\u002F=40%, where their panel of patients over the last year included at least 10 patients with heart failure with reduced ejection fraction (HFrEF)\n\nPatient:\n\n* Age \\> 18 years\n* LVEF \\\u003C\u002F=40% on most recent cardiology imaging study\n* Has a new or return clinic visit with an enrolled clinician within the next 7 days\n* Is missing at least one of the four classes of medications and does not have an allergy to that class: (1) beta blockers, (2) angiotensin receptor-neprilysin inhibitor, (3) aldosterone receptor antagonists, (4) sodium-glucose co-transporter\n\nExclusion Criteria:\n\nPatient:\n\n* Has a left ventricular assist device\n* Under evaluation for or listed for transplant (or s\u002Fp transplant)\n* Glomerular filtration rate (GFR) less than 20 or on dialysis\n* On hospice care\n* Preferred language neither English or Spanish","ALL","18 Years",{"count":21,"type":22},2200,"ESTIMATED","INTERVENTIONAL",[25],"NA","An increasing number of guideline-directed medical therapies (GDMT) have been developed for patients with chronic heart failure with reduced ejection fraction (HFrEF). When used in combination at recommended doses, patients often experience significant improvements in cardiac function, quality of life, and survival.1,2 However, GDMT underuse occurs for the vast majority of patients with HFrEF. Two recent trials demonstrated improved GDMT prescribing during a clinic visit, each using automated delivery of a patient-centered decision support tool to promote a proactive and holistic approach to prescribing: EPIC-HF (NCT03334188) tested a brief video and checklist document sent to patients just prior to a clinic visit encouraging them to work with their clinicians to make at least 1 positive change to their GDMT; PROMPT-HF (NCT05433220) tested tailored electronic health record (EHR) alerts for GDMT intensification delivered to clinicians during clinic visits. The current I-I-CAPTAIN-HF study aims to broadly implement and test the EPIC-HF patient-facing and PROMPT-HF clinician-facing tools for HFrEF medication intensification at 5 health systems around the country through a pragmatic cluster-randomized implementation-effectiveness trial. This will occur through an initial phase of adaptation of the 2 tools at each health system. Once ready, the 2 tools will be tested using a 2x2 randomization at the clinician-level. In parallel, formal assessment of the implementation of EPIC-HF and PROMPT-HF will work to understand the most effective means of intervention design and delivery, as well as adaptations due to contextual factors to optimize use.",[28],"Heart Failure With Reduced Ejection Fraction",[30,31,32,33],"Heart failure","Patient-centered care","Clinical decision support","Guideline-directed medical therapy","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2025-03-06",{"date":42,"type":22},"2028-09-01",{"name":44,"class":45},"University of Colorado, Denver","OTHER",5,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100630622","phase-4-mechanistic-clinical-trial-comparing-the-pharmacokineticspharmacodynamics-of-metoprolol-in-heart-failure-with-reduced-ejection-fraction-patients-with-low-vs-high-polygenic-score-100630622","NCT07490067","Mechanistic Clinical Trial Comparing the Pharmacokinetics\u002FPharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score","Personalizing Heart Failure Treatment With Genomics: A Clinical Trial to Understand the Mechanisms and Validate a Polygenic Risk Score for Beta-Blocker Response","Inclusion Criteria:\n\n* Heart Failure with Reduced Ejection Fraction (HFrEF)\n* Has not taken a beta-blocker within the past 6 months (preferred), or if needed to meet enrollment target, patients that have not taken a beta-blocker in the past 3 months, or only taken a low dose of beta-blocker within the past 6 months (i.e., \\\u003C 50% of the guideline-recommended HFrEF target dose, or for beta-blockers that are not approved for HFrEF, \\\u003C50% of the maximum dose)\n* Genetic data already available to calculate the polygenic score (e.g., through participation in the Michigan Genomics Initiative (MGI) or other genetic tests) or willingness to provide a deoxyribonucleic acid (DNA) sample for genetic analysis\n* White race\n* Has been prescribed a stable dose (including no dose) of angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), ARB-neprilysin inhibitor (ARNI), sodium-glucose cotransporter 2 (SGLT-2) inhibitor, or mineralocorticoid receptor antagonist (MRA) for at least the past 4 weeks\n* Has been prescribed a stable dose (including no dose) of diuretic(s) for at least the past 2 weeks\n* For women of child-bearing potential: the participant is willing to perform a pregnancy test and use a highly effective contraceptive method for at least 4 weeks prior to the start of metoprolol treatment, during the entire metoprolol treatment period, and for at least 5 days after the discontinuation of metoprolol treatment\n* Ability to understand and willing to sign a written informed consent\n\nExclusion Criteria:\n\n* Prior heart transplant or left ventricular assist device (LVAD) or planned within treatment period\n* Planned implantation of a pacemaker or Cardiac Resynchronization Therapy (CRT) during treatment period\n* Patients with a pacemaker that does not allow their heart rate to change in response to exercise per protocol\n* Pregnant\n* Systolic blood pressure \\\u003C 95 millimeters of mercury (mmHg)\n* Heart rate \\\u003C 60 beats per minute\n* Second (Mobitz II)- or third-degree heart block\n* Cardiogenic shock\n* Patients with acute decompensated heart failure requiring current hospitalization or immediate medical intervention.\n* Sick sinus syndrome\n* Pheochromocytoma\n* Known hypersensitivity to the metoprolol succinate oral tablet used in the trial\n* Hypertrophic obstructive cardiomyopathy\n* Active myocarditis\n* Acute coronary syndrome within the past month\n* Active or uncorrected severe mitral or aortic valvular dysfunction\n* Patients with known severe congenital heart disease per protocol\n* Child-Pugh Class C liver disease\n* Patients with end-stage renal disease (ESRD) requiring hemodialysis\n* Concomitant disease that prohibits participating in Cardiopulmonary Exercise Test (CPET) per protocol\n* Concomitant disease with expected survival less than the duration of the study (e.g., metastatic cancer)\n* Current or planned treatment with cardiotoxic medications, including interferons and the cancer therapies per protocol\n* Concurrent participation in another clinical trial that may affect participant safety or validity of data collected in this clinical trial\n* Inability to take oral medication\n* Unwilling or unlikely to adhere to the study procedures, as determined at the discretion of the study team, including but not limited to the following reasons:\n\n  1. Psychiatric illness or other comorbidities\n  2. Substance abuse\n  3. Social or logistical circumstances",{"count":55,"type":22},100,[57],"PHASE4","The purpose of this trial is to better understand how the beta-blocker metoprolol works in people with Heart Failure with Reduced Ejection Fraction (HFrEF) according to participants genetics. Participants will have the beta-blocker (BB) polygenic score calculated from genotype data. The score will be used to stratify the patients in the low and high polygenic score groups in the study.\n\nThe hypotheses for this trial are:\n\n* HFrEF patients with high polygenic score will have weaker cardiovascular responses to metoprolol succinate than HFrEF patients with low polygenic score.\n* HFrEF patients with high polygenic score have lower steady-state plasma concentrations of metoprolol succinate than HFrEF patients with low polygenic score.\n* HFrEF patients with high polygenic score require higher metoprolol succinate plasma concentrations to achieve similar cardiovascular effects as those with low polygenic score.",[28],[61,62,63,64,65,66,67],"Beta-blocker","Polygenic Risk Score","Pharmacokinetic","Pharmacogenomics","Pharmacodynamics","Pharmacogenetic","Cardiac testing","2026-06-29",{"date":70,"type":38},"2026-06-30",{"date":72,"type":22},"2026-07",{"date":74,"type":22},"2029-07",{"name":76,"class":45},"University of Michigan",1,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":77},"100534638","the-cardioclip-study-100534638","NCT06241430","The CardioClip Study","Hemodynamic-Guided Optimization With the CardioMEMS Device of Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Mitral Transcatheter Edge-to-Edge Repair With the MitraClip Device","CardioClip","Inclusion Criteria:\n\n* Significant (moderate-severe \\[3+\\] or severe \\[4+\\] secondary MR)\n* Left ventricular dysfunction (ejection fraction \\>20% and \\\u003C50%)\n* New York Heart Association (NYHA) class II-IVa symptoms\n* Sign informed consent to participate in the study\n\nExclusion Criteria:\n\n* Left ventricular (LV) end-systolic dimension 70 mm\n* PA systolic pressure 70 mmHg (fixed)\n* Mitral valve (MV) orifice area \\\u003C4.0 cm2\n* Commissural MR jet or leaflet anatomy not suitable for mTEER\n* Likely to undergo heart transplantation or LV assist device implantation in the next 12 months\n* Recurrent (i.e., \\>1) pulmonary embolism or deep vein thrombosis\n* Complex congenital heart disease\n* Mechanical right heart valve (tricuspid or pulmonic)\n* Cardiac resynchronization therapy implanted within 3 months of enrollment\n* Hypersensitivity to aspirin and\u002For clopidogrel\n* History of medication non-adherence","90 Years",{"count":5,"type":22},[25],"The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.",[28,91],"Mitral Regurgitation",[30,93,94,95,96,97,98,99,100,101],"Reduced ejection fraction","Mitral regurgitation","mTEER (mitral transcatheter edge-to-edge repair)","CardioMems (implantable pulmonary artery pressure sensor)","Guideline-directed medical therapy (GDMT)","HF hospitalization (HFH)","Clinical trial","Hemodynamic monitoring","Cardiovascular outcomes","2026-06-25",{"date":68,"type":38},{"date":105,"type":38},"2024-12-18",{"date":107,"type":22},"2030-06",{"name":109,"class":45},"Columbia University",{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":139},"100572692","phase-3-study-with-omecamtiv-mecarbil-ck-1827452-to-treat-chronic-heart-failure-with-severely-reduced-ejection-fraction-100572692","NCT06736574","Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction","A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)","COMET-HF","Inclusion Criteria:\n\nAdult patients who meet all the following criteria at screening may be included in the study:\n\n* Are between ≥ 18 years and ≤ 85 years at the signing of informed consent\n* Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening\n* Are receiving oral loop diuretics on a regular schedule\n* Patients without AFF on screening ECG:\n\n  * LVEF \\\u003C 30% within 6 months of screening\n  * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg\u002FmL (BNP ≥ 300 pg\u002FmL)\n* Patients with AFF on screening ECG:\n\n  * LVEF \\\u003C 25% within 6 months of screening\n  * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg\u002FmL (BNP ≥ 900 pg\u002FmL)\n  * Not currently taking digoxin\n* Meet one of the following criteria for a recent HF event:\n\n  * Are currently hospitalized with the primary reason of HF\n  * Had an HF event (as defined in the primary endpoint) within 12 months prior to screening. For the purposes of a qualifying HF event, subcutaneous furosemide will be treated as equivalent to intravenous furosemide Or\n  * Had outpatient escalation of oral diuretics due to worsening signs and symptoms of heart failure plus one of two additional criteria sustained for at least 1 week: (1) at least 50% or 1.5-fold increase in daily loop-diuretic-equivalent dose; (2) the addition of a new diuretic class to a loop diuretic.\n* Are established on regional standard-of-care HF therapies for at least 30 days prior to screening\n* Systolic blood pressure ≤ 140 mmHg\n\nExclusion Criteria:\n\nAny of the following criteria will exclude potential patients from the study:\n\n* Have AFF on the screening ECG and are currently taking digoxin\n* Have had any event or procedure that may have resulted in a change in ejection fraction, including, but not limited to, acute coronary syndrome and\u002For any coronary revascularization, cardiac surgery, valve surgery, any coronary revascularization, and\u002For cardiac resynchronization, or cardiac contractility modulation therapy within 3 months of screening\n* Are admitted to a long-term care facility or hospice\n* Have a projected survival of \\\u003C 12 months due to non-cardiovascular causes based on clinical judgment\n* Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening\n* Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening\n* Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening (except for nocturnal supplemental oxygen for sleep apnea or heart failure)\n* Have an estimated glomerular filtration rate (eGFR) \\\u003C 20 mL\u002Fmin\u002F1.73m2 or receiving dialysis at screening\n* Have previously had a solid organ transplant\n* Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening\n* Have received omecamtiv mecarbil in a previous clinical trial\n* Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP\n* Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease","85 Years",{"count":120,"type":22},1800,[122],"PHASE3","The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.",[125,28],"Heart Failure",[127,128],"CK-1827452","omecamtiv mecarbil","2026-06-23",{"date":131,"type":38},"2026-06-24",{"date":133,"type":38},"2024-12-19",{"date":135,"type":22},"2027-12",{"name":137,"class":138},"Cytokinetics","INDUSTRY",188,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":77},"100548638","phase-2-effect-of-weight-loss-on-physical-and-cardiac-performance-in-people-with-obesity-and-heart-failure-100548638","NCT06423599","Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure","FIT-HF","Inclusion Criteria:\n\n* Male or female, age ≥ 18 years at the time of signing informed consent\n* Body mass index (BMI) ≥ 30 kg\u002Fm2\n* Heart failure with New York Heart Association (NYHA)-class 1-3 and reduced ejection fraction (EF≤40%) established by either:\n\n  1. echocardiography AND\u002FOR\n  2. cardiac magnetic resonance\n* On stable optimal medical heart failure therapy for at least 4 weeks\n\nExclusion Criteria:\n\n1. Cardiovascular-related:\n\n   * Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 6 months prior to the day of screening\n   * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening\n   * Transient heart failure related to reversible mechanisms like tachycardia, sepsis, etc.\n2. Glycaemia-related:\n\n   * Type 1 diabetes\n   * Treatment with any Glucagon-Like Peptide-1 (GLP-1) agonists within 90 days prior to the day of screening\n   * Type 2 diabetes requiring other pharmacotherapy than metformin and Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors\n3. General safety:\n\n   * Pregnancy or planned pregnancy\n   * History or presence of chronic pancreatitis\n   * Presence of acute pancreatitis within the past 180 days prior to the day of screening\n   * Kidney disease with eGFR \\\u003C 35ml\u002Fmin\n   * Presence or history of malignant neoplasms within the past 5 years prior to the day of screening (Basal and squamous cell skin cancer and any carcinoma in-situ are allowed)\n   * Known or suspected hypersensitivity to trial product(s) or related products",{"count":55,"type":22},[149,122],"PHASE2","The benefit of weight loss in patients with obesity and heart failure with reduced ejection fraction (HFrEF) is controversial. Semaglutide has shown cardiovascular (CV) risk-reduction and impact on CV risk factors including overweight, dysglycaemia and hypertension in subjects with type 2 diabetes (T2D). The STEP-HFpEF (Semaglutide Treatment Effect in People With Obesity and HFpEF) recently demonstrated, at 1-year, to not only reduce weight considerably, but also significantly improve health-related quality of life, functional status scores and 6-min walk distance in patients with heart failure with preserved ejection fraction (HFpEF). Also, the recently concluded SELECT trial was the first CV outcome trial with semaglutide in patients with overweight or obesity and established CV disease, including heart failure (but no T2D). Semaglutide demonstrated a 20% reduction in MACE, defined as the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.\n\nThese landmark findings have important implications for clinicians -as they mean that weight loss and\u002For semaglutide as anti-obesity pharmacotherapy could be a treatment strategy for secondary prevention of CV disease in patients with overweight or obesity.\n\nIt is, however, unknown whether weight loss with either calorie-restricted diet or semaglutide has beneficial effects in obese subjects with heart failure and reduced ejection fraction. Also it is unclear whether semaglutide has cardiovascular benefits irrespective of starting weight and amount of weight loss.\n\nPurpose: The study aims to investigate whether weight loss treatment with semaglutide is superior to weight loss with calorie-restricted diet in improving peak oxygen uptake in patients with obesity and heart failure with reduced ejection fraction.",[28,152,153,154],"Obesity","Weight Loss","Chronic Heart Failure","2026-06-22",{"date":129,"type":38},{"date":158,"type":38},"2024-04-30",{"date":160,"type":22},"2027-12-30",{"name":162,"class":45},"Jens D Hove, MD,PHD",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":18,"minAge":171,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":191,"leadSponsor":193,"locationsCount":46},"100639301","phase-4-stepwise-de-escalation-and-optimizing-withdrawal-of-arni-and-sglt2i-in-normalized-heart-failure-100639301","NCT07631156","STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure","STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure (STEP-DOWN HF Trial)","STEP-DOWN HF","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Prior left ventricular ejection fraction (LVEF) ≤40% before surgery or intervention, with recovery to ≥50% (normalized range) at the time of enrollment\n* N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\\u003C250 ng\u002FL\n* Complete correction of a reversible underlying cause of heart failure: surgical or transcatheter correction of valvular heart disease (mitral regurgitation, aortic stenosis, aortic regurgitation), or percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for ischemic cardiomyopathy\n* Currently receiving both ARNI and SGLT2i for at least 3 months at enrollment (MRA and\u002For beta-blocker may also be used)\n* Clinically stable outpatient with no heart failure-related hospitalization within the prior 6 months\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Heart failure due to irreversible etiology (e.g., idiopathic dilated cardiomyopathy, toxic cardiomyopathy, genetic cardiomyopathy)\n* For valvular disease: moderate or greater paravalvular leak, or residual moderate or greater mitral or aortic regurgitation\n* For ischemic disease: incomplete revascularization or graft occlusion on post-operative coronary CT\n* Chronic kidney disease stage 4 or higher (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n* Symptomatic hypotension (systolic blood pressure \\\u003C90 mmHg) or symptomatic bradycardia (heart rate \\\u003C50 beats\u002Fmin)\n* Pregnant, suspected pregnancy, or breastfeeding\n* Terminal malignancy or end-stage organ failure with life expectancy \\\u003C12 months\n* Participation in another clinical trial within 3 months prior to screening\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for the study","19 Years",{"count":173,"type":22},80,[57],"This is a multicenter, randomized, open-label pilot study to evaluate whether stepwise withdrawal of two heart failure medications-angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitor (SGLT2i)-is safe in patients with Heart Failure with improved Ejection Fraction (HFimpEF) whose underlying structural cause (valvular heart disease or ischemic cardiomyopathy) has been completely corrected by surgery or intervention.\n\nEighty adult patients (40 per arm) whose left ventricular ejection fraction (LVEF) has recovered to 50% or higher and whose NT-proBNP is ≤ 250 ng\u002FL will be randomized 1:1 to either (1) stepwise withdrawal of ARNI followed by SGLT2i over one month under close echocardiographic monitoring, or (2) continuation of their current guideline-directed medical therapy.\n\nThe primary outcome is the change in LVEF at 12 months, with non-inferiority of the withdrawal strategy declared if the LVEF decline is within 5 percentage points of the continuation arm. Secondary outcomes include cardiovascular death, heart failure hospitalization, NT-proBNP, quality of life (KCCQ-12), 6-minute walk distance, and adverse events.\n\nResults from this pilot will inform the design and sample size of a subsequent definitive non-inferiority trial and may provide initial evidence to guide deprescribing decisions in clinical practice.",[28,125,177],"Ventricular Dysfunction, Left",[179,180,181,182,183,184,185,186],"HFimpEF","ARNI","Sacubitril\u002FValsartan","SGLT2 Inhibitor","Guideline-Directed Medical Therapy","Reverse Remodeling","Valvular Heart Disease","Ischemic Cardiomyopathy","NOT_YET_RECRUITING","2026-06-21",{"date":131,"type":38},{"date":70,"type":22},{"date":192,"type":22},"2029-12-30",{"name":194,"class":45},"Kyungsub Song",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":205,"phases":4,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100599678","deep-learning-detection-of-pulmonary-hypertension-and-low-ejection-fraction-via-digital-stethoscope-and-3-lead-ecg-100599678","NCT07087613","Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG","Deep Learning for Detection of Pulmonary Hypertension and Reduced Left Ventricular Ejection Fraction Using a Combined Digital Stethoscope and Three-lead Electrocardiogram","PH ELEFT 2-0","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Able and willing to provide informed consent\n* Completed a clinical echocardiogram or right heart catheterization within 7 days before or after study procedures\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent\n* Patients who are hospitalized\n* Patients undergoing echocardiography with a limited echocardiogram (does not apply to patients undergoing right heart catheterization)",{"count":204,"type":22},3850,"OBSERVATIONAL","This is a prospective, observational study evaluating whether heart sounds (phonocardiograms) and three-lead electrocardiograms (ECGs) recorded using the Eko CORE 500 digital stethoscope can help detect pulmonary hypertension (PH) and low left ventricular ejection fraction (EF ≤ 40%). PH is a condition characterized by high blood pressure in the pulmonary arteries, which can lead to heart failure and carries significant risks if undiagnosed. Low EF, which indicates reduced pumping ability of the heart, is also associated with increased risk of severe cardiac events but can remain undetected because patients often have no symptoms or only nonspecific symptoms.\n\nIn this study, adults undergoing clinically indicated echocardiograms or right heart catheterization at outpatient sites will be invited to participate. Participants will complete a single study session lasting about 20 minutes, during which heart sounds and a three-lead ECG will be collected using the Eko CORE 500 device. If participants have had a clinical 12-lead ECG within 30 days of their echocardiogram or right heart catheterization, those data may also be used for analysis. A clinically indicated echocardiogram or right heart catheterization (RHC) performed within seven days before or after the Eko CORE 500 recording will serve as the reference standard to confirm the presence or absence of PH and low EF.\n\nUp to 3,850 participants may be enrolled across multiple sites to ensure that approximately 3,500 complete the study. The data collected will be used to develop and validate artificial intelligence (AI) algorithms that aim to detect PH and identify low EF, potentially enabling earlier and simpler screening for these conditions in clinical practice.",[208,28],"Hypertension, Pulmonary","2026-06-16",{"date":211,"type":38},"2026-06-18",{"date":213,"type":38},"2025-06-15",{"date":215,"type":22},"2027-05-31",{"name":217,"class":138},"Eko Devices, Inc.",4,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":77},"100619850","pci-with-gdmt-versus-gdmt-alone-for-patients-with-ischemic-cardiomyopathy-and-reduced-lvef-100619850","NCT07349979","PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF","Percutaneous Coronary Intervention With Guideline-Directed Medical Therapy Versus Guideline-Directed Medical Therapy Alone for Patients With Ischemic Cardiomyopathy and Reduced Left Ventricular Ejection Fraction: A Randomized, Controlled, Open-Label, Multicenter PCI-GULF Trial","PCI-GULF","Inclusion Criteria:\n\n1. Age ≥18 years at screening.\n2. Documented LVEF ≤40% assessed by quantitative transthoracic echocardiography confirmed at the core laboratory within 90 days prior to randomization.\n3. Symptomatic heart failure (NYHA Functional Class II, III, or ambulatory Class IVa) or hospitalization for heart failure within the prior 12 months or NT-proBNP ≥600 pg\u002FmL.\n4. Angiographically proven CAD with at least one lesion with 1) a visually estimated diameter stenosis (DS) of ≥90% or 2) chronic total occlusion with a high likelihood (\\>80%) of PCI success, or 3) a visually estimated DS of \\\u003C90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions considered amenable to PCI with DES by an interventional cardiologist.\n5. On stable GDMT for at least 4 weeks prior to randomization under the advisor's assessment at each site.\n6. The subject, or their legal guardian, has a clear understanding of the trial's design and procedures, provide written informed consent, and is able to comply with all follow-up procedures.\n\nExclusion Criteria:\n\n1. Class III or IV angina requiring revascularization.\n2. Any unplanned hospitalization within 30 days.\n3. Any PCI within 12 months.\n4. Any prior CABG.\n5. Cardiogenic shock or end-stage heart failure (NYHA class IVb - unable to ambulate)\n6. Non-cardiac life expectancy \\\u003C1 year at screening (e.g., malignancy, advanced liver disease).\n7. Coronary anatomy requiring surgical revascularization by local heart team determination.\n8. Coronary anatomy unsuitable for PCI.\n9. HF due to specific cardiomyopathies, including restrictive\u002Finfiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM).\n10. Severe stenosis or regurgitation of any heart valve.\n11. Contraindication to dual antiplatelet therapy or iodinated contrast.\n12. Pregnancy, lactation, or women of childbearing potential not using effective contraception. A negative urine pregnancy test is required within 7 days prior to randomization for women of childbearing potential.\n13. Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol.\n14. Any other circumstances that the investigator deems inappropriate for participation, including but not limited to conditions that may jeopardize patient safety, confound data interpretation, or patients unlikely to comply with study procedures.",{"count":228,"type":22},1154,[25],"To evaluate whether percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) combined with guideline-directed medical therapy (GDMT), compared to GDMT alone, reduces the time to first occurrence of major adverse cardiovascular events (MACE) during a median follow-up of at least 24 months, measured at the time the last enrolled patient reaches 12 months, in patients with ischemic cardiomyopathy and left-ventricular ejection fraction (LVEF) ≤40%. MACE is a composite of cardiovascular \\[CV\\] death, myocardial infarction (MI), heart failure (HF) related rehospitalization, heart transplantation, requirement for durable left ventricular assist device \\[LVAD\\] implantation, or worsening heart failure treated as an out-patient requiring treatment with intravenous medications.",[28,232,233],"Coronary Artery Disease","Stable GDMT",[235,236,237,238],"HFrEF","PCI","GDMT","MACE","2026-05-24",{"date":241,"type":38},"2026-05-28",{"date":243,"type":22},"2026-12-30",{"date":245,"type":22},"2028-01-30",{"name":247,"class":45},"Nanjing First Hospital, Nanjing Medical University",{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":77},"100641083","strategy-success-in-high-risk-pci-with-impella-cp-evaluation-of-hemodynamic-protection-in-complex-pci-100641083","NCT07588399","STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI","Randomized Pilot Study to Mechanistically Evaluate Automatic Flow Mode on Impella CP Device During Protected Complex Percutaneous Coronary Intervention","STRATUS-PCI","Inclusion Criteria:\n\n* signed written informed consent\n* age ≥ 18 years\n* presentation in chronic coronary syndrome or acute coronary syndrome (STEMI ≥ 24h)\n* LV-EF ≤ 40 % and one of the following parameters:\n\nLast remaining artery Unprotected LM-PCI + severe RCA stenosis or CTO Unprotected LM-PCI + left dominance Unprotected LM-PCI + severe aortic stenosis Unprotected LM-PCI + severe mitral regurgitation RCA PCI + unprotected severe LM stenosis RCA PCI + proximal LAD stenosis + proximal LCx stenosis\n\nExclusion Criteria:\n\n* no written informed consent\n* pregnancy\n* acute infection\n* recent ST-elevation myocardial infarction (\\\u003C 24 hours) or not normalized CK-MB enzymes",{"count":257,"type":22},50,[25],"STRATUS-PCI is a pilot clinical trial that compares two ways of running a small heart pump called Impella CP during a high-risk procedure to open blocked heart arteries (percutaneous coronary intervention, or PCI) in patients with weakened heart muscle. The pump is placed temporarily through an artery in the leg and sits across the aortic valve to help maintain blood flow during the procedure.\n\nFifty patients will be randomly assigned in equal numbers to one of two pump settings: an automatic mode that adjusts flow up to higher levels as needed, or a fixed lower-flow mode (P-2). The doctor performing the heart procedure will not know which setting is being used (double-blind). A separate doctor monitors blood pressure and is allowed to change the pump setting at any time if the patient becomes unstable.\n\nThe main question is whether the automatic mode helps doctors complete the planned heart procedure more successfully and without drops in blood pressure or other complications. Results will help design a larger future trial.",[232,28],[262,263,264,265,266,254],"Impella CP","Mechanical Circulatory Support","Protected PCI","High-Risk PCI","Hemodynamic Support","2026-05-22",{"date":269,"type":38},"2026-05-27",{"date":271,"type":22},"2026-07-01",{"date":273,"type":22},"2027-10-01",{"name":275,"class":45},"Rayyan Hemetsberger",{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":46},"100573526","high-fat-diet-for-cardiac-metabolic-reprogramming-100573526","NCT06747429","High Fat Diet for Cardiac Metabolic Reprogramming","Cardiac Metabolic Reprogramming by a Nutritional Intervention: the High Fat Diet for Heart Failure (HF4HF) Study, a proof-of Concept Randomized Controlled Trial","HF4HF","Inclusion Criteria:\n\n* Patients of both sexes and ≥18 years old\n* Patients diagnosed with HF secondary to non-ischemic DCM, according to ESC guidelines definition,1 with or without a known genetic basis.\n* LVEF ≤49% according to the baseline CMR.\n* Optimized HF guideline-directed medical therapy for at least 3 months prior to inclusion.\n* Patients who have provided informed consent.\n\nExclusion Criteria:\n\n* Prior diagnosis of ischemic DCM.\n* Prior diagnosis of established atherosclerotic cardiovascular disease (angina\u002Fmyocardial infarction, transient ischemic attack\u002Fstroke, lower limb ischemia or at any other peripheral level).\n* Changes in HF therapies within the last 3 months.\n* HF decompensation within the previous 3 months, including HF hospitalization or the need of ambulatory intravenous diuretic or inotropic treatment such as levosimendan.\n* Uncontrolled dyslipidemia, defined as LDL-cholesterol \\>160 mg\u002FdL and\u002For triglycerides \\>200 mg\u002FdL, despite treatment.\n* Any contraindication for CMR:\n\nSevere claustrophobia. Any device which is known to threaten or pose hazard in all MR environments. \u002F\u002Fwww.mrisafety.com\u002F Patients with implanted biomedical devices (cardiac artefacts): pacemakers, cardiac defibrillators or cardiac resynchronization therapy.\n\n* Liver and biliary diseases, including prior diagnosis of non-alcoholic fatty liver disease and unoperated cholelithiasis.\n* Prior episodes of acute pancreatitis or chronic pancreatitis.\n* Prior fish or nut allergy.\n* Life expectancy less than 12 months.\n* Pregnancy or planned pregnancy for the next 4 months.\n* Current lactation.\n* Patients participating in other randomized clinical trial.\n* Impossibility to consent or undergo study follow-up",{"count":173,"type":22},[25],"Heart failure (HF) continues to be a leading cause of morbidity and mortality worldwide, despite advances in treatment. HF is often characterized by an altered metabolism in the heart, where glucose is favored over fatty acids as the primary energy substrate. This metabolic shift has been hypothesized to contribute to disease progression. Previous studies using animal models have demonstrated that restoring fatty acid metabolism through dietary intervention can reverse the adverse metabolic effects and improve heart function. A transgenic murine model with mitochondrial defects, for instance, exhibited improved cardiac function after an HFD intervention. These findings were reinforced by a translational pig model of non-ischemic DCM, where a high-fat diet significantly improved LVEF compared to a standard diet.\n\nBuilding upon these promising preclinical results, a small-scale human study showed that lipid infusion, rather than glucose, improved cardiac function in HF patients. However, the long-term benefits of a HFD in heart failure patients have yet to be thoroughly explored. The HF4HF trial aims to fill this gap by evaluating the effects of an HFD over a two-month period in patients with non-ischemic DCM and reduced LVEF.\n\nThe \"High Fat Diet for Heart Failure\" (HF4HF) study is a proof-of-concept randomized controlled trial designed to investigate the efficacy of a high-fat diet (HFD) as a therapeutic intervention in patients with non-ischemic dilated cardiomyopathy (DCM) and reduced left ventricular ejection fraction (LVEF). The study hypothesizes that cardiac metabolic reprogramming, achieved through a controlled nutritional intervention involving an HFD, can enhance systolic function, myocardial energetics, and overall heart function in heart failure (HF) patients. Cofunded by the European Commission and national entities, the trial is spearheaded by a consortium of cardiovascular research centers across four countries: Spain, Italy, France, and Romania.",[288,28],"Non-ischemic Dilated Cardiomyopathy",[290,291,292,293],"heart failure","high-fat diet","clinical trial","non-ischemic DCM","2026-05-21",{"date":296,"type":38},"2026-05-26",{"date":298,"type":38},"2026-01-15",{"date":300,"type":22},"2026-12",{"name":302,"class":45},"Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III",{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":315,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":4},"100636742","phase-3-hfref-polypill-in-sri-lanka-rct-100636742","NCT07569640","HFrEF Polypill in Sri Lanka RCT","Heart Failure With Reduced Ejection Fraction Polypill in Sri Lanka: A Multi-Center Type I Hybrid Randomized Controlled Trial","Inclusion Criteria:\n\n1. Adults (≥18 years old)\n2. Diagnosis of heart failure with reduced ejection fraction (HFrEF) including clinical symptoms or clinical signs or natriuretic peptide elevation AND echocardiographic or other evidence of reduced ejection fraction (EF≤40%)\n3. New York Heart Association Class II, III, or IV symptoms\n\nExclusion Criteria:\n\n1. Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others).\n2. Significant renal impairment (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n3. Raised serum potassium \\>5 mEq\u002FL.\n4. Symptomatic hypotension or systolic BP \\\u003C100 mmHg as per the average of last 2 of the 3 measurements at visit 1.\n5. Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1.\n6. History of type 1 diabetes mellitus.\n7. Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).\n8. Concomitant illness, physical impairment or mental condition which in the opinion of the study team\u002F primary physician could interfere with the conduct of the study including outcome assessment.\n9. Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.\n10. Participant's responsible physician believes it is not appropriate for participant to participate in the study.\n11. Inability or unwillingness to provide written informed consent.\n12. Involvement in the planning and\u002For conduct of the study.\n13. Unable to complete study procedures and\u002For plan to move out of the study site area in the next 2 months.",{"count":311,"type":22},1656,[122],"Primary Outcome:\n\nComposite of cardiovascular death or recurrent heart failure hospitalization over study duration\n\nSecondary Outcomes:\n\nCardiovascular death over study duration Recurrent heart failure hospitalizations over study duration All-cause mortality over study duration Change in left ventricular ejection fraction from baseline to 12 months by echocardiogram.\n\nChange in natriuretic peptide levels from baseline to 12 months. Change in health-related quality of life from baseline to 12 months using the Kansas City Cardiomyopathy Questionnaire.\n\nChange in New York Heart Association functional class from baseline to 12 months.\n\nAdherence to heart failure medications assessed by pill count and questionnaire, medication persistence assessed as continuation of assigned therapy after initiation, and dose optimization assessed as proportion achieving final\u002Ftarget doses over study duration\n\nSafety Outcomes:\n\nProportion of participants with serious adverse events or sudden unexpected serious adverse reaction over study duration Proportion with adverse events of special interest (symptomatic hypotension, diabetic ketoacidosis, severe hypoglycemia, lower limb amputation, hyperkalemia, or worsening kidney function) over study duration Proportion of participants who stop study drug because of adverse events over study duration Change in serum potassium over study duration Change in serum creatinine over study duration\n\nParticipants will be randomly assigned to one of two groups, intervention or usual care. The intervention group will be given four guideline-recommended medications for heart failure with reduced ejection fraction, combined in one over-encapsulated pill, with three dose strength options (at the discretion of their treating physician). Both groups will be observed over a minimum of 12-months of follow-up to assess their medication adherence, clinical symptoms, laboratory measures, health related quality of life, and need for medication adjustment amongst other measures.",[28],[235,125,316,317,318,319],"Heart Failure with Reduced Ejection Fraction","South Asia","Sri Lanka","Polypill","2026-05-14",{"date":322,"type":38},"2026-05-18",{"date":324,"type":22},"2026-06-01",{"date":326,"type":22},"2029-03-01",{"name":328,"class":45},"Washington University School of Medicine",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":18,"minAge":335,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":77},"100637416","dietary-intervention-and-physical-activity-in-patients-with-heart-failure-and-reduced-ejection-fraction-100637416","NCT07595809","Dietary Intervention and Physical Activity in Patients With Heart Failure and Reduced Ejection Fraction","Inclusion Criteria:\n\nWritten informed consent obtained prior to participation Age \\>30 years Diagnosis of chronic heart failure, NYHA functional class I-III Left ventricular ejection fraction \\\u003C40%\n\nExclusion Criteria:\n\nNYHA functional class IV heart failure Potentially reversible cause of heart failure Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin Severe anemia (hemoglobin \\\u003C9 g\u002FdL) Uncontrolled thyroid disease Severe hepatic dysfunction History of hyperkalemia or hyperkalemia at baseline Epilepsy Presence of joint endoprostheses Gastrointestinal disorders limiting adherence to the DASH diet Physical limitations precluding participation in structured exercis","30 Years",{"count":55,"type":22},[25],"Heart failure with reduced ejection fraction (HFrEF) is frequently associated with abnormalities in body composition, including reduced skeletal muscle mass and sarcopenia, which are independent predictors of reduced exercise tolerance, impaired quality of life, and increased mortality. Despite advances in pharmacological therapy, evidence-based non-pharmacological strategies aimed at preventing muscle mass loss remain limited.\n\nThis randomized controlled trial aims to evaluate the effects of dietary intervention based on the DASH diet with high-protein elements, resistance exercise training, and their combination on skeletal muscle mass, functional capacity, echocardiographic parameters, biochemical markers, and quality of life in patients with HFrEF.",[28],"2026-05-13",{"date":342,"type":38},"2026-05-19",{"date":344,"type":38},"2023-05-08",{"date":346,"type":22},"2027-04",{"name":348,"class":45},"Medical University of Silesia",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":360,"conditions":361,"keywords":364,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":370,"leadSponsor":372,"locationsCount":4},"100547252","phase-2-midodrine-in-heart-failure-with-reduced-ejection-fraction-with-hypotension-100547252","NCT06405555","Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension","Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension: A Pilot, Open-label, Randomized Controlled Trial","MIDOH-HF-P","Inclusion Criteria:\n\n* Adults \\>= 18 years of age.\n* LVEF \\\u003C= 40 % within the last 3 months as determined by any one of: Transthoracic echocardiogram, transesophageal echocardiogram, cardiac magnetic resonance imaging, MUGA scan, angiogram with left ventriculogram.\n* AHA\u002FACC Stage B or C Heart Failure\n* Hospitalized patients in the ward setting OR in the cardiac intensive care unit (who are \\>= 48 hours after their last dose of vasopressor or inotrope).\n* Seated upright or supine SBP \\\u003C= 100 mmHg on two or more consecutive BP measurements separated by at least 8 hours\n\nExclusion Criteria:\n\n* Patient OR substitute decision-maker (SDM) unwilling or unable to provide informed consent\n* Documented allergy or intolerance to midodrine\n* Treatment for active infection (either documented infection or empiric treatment) with antimicrobials at the time of recruitment.\n* Current use OR any use within the last 48 hours of an intravenous inotrope or vasopressor medication OR the need for IV inotrope or vasoproessor use to treat hypotension\n* Patient within 72 hours of an acute coronary syndrome.\n* Heart transplant recipient.\n* Presence of temporary or durable mechanical circulatory support device.\n* Severe valvular disease expected to be intervened upon during the incident hospitalization.\n* Hyperkalemia \\>= 5.5 mmol\u002FL.\n* Baseline eGFR (as calculated by the CKD-EPI method) \\\u003C= 20 mL\u002Fmin\u002F1.73 m2 as measured within the last 3 months.\n* A treatable cause for hypotension, including but not limited to: hypovolemia (eg. Bleeding, overdiuresis, poor oral intake), obstructive shock, sepsis, adrenal insufficiency.\n* Clinical diagnosis of ongoing cardiogenic shock, or diagnosed as defined in SHOCK trial: sBP \\\u003C= 90 mmHg with evidence of end-organ hypoperfusion (cool extremities, urine output \\\u003C 30 mL\u002Fhr, HR \\> 60 bpm, or elevated lactate \\>=3.5 mmol\u002FL), invasive hemodynamic measurements (if available) of CI \\\u003C= 2.2 L\u002Fmin\u002Fm2 and a pulmonary capillary wedge pressure (PCWP) of \\>=15 mmHg.\n* Pregnant patient.\n* Anticipated patient discharge in less than two days from enrolment (ie. less than 6 anticipated doses of midodrine, if randomized to treatment\u002Fintervention arm).\n* Acute brain pathology (including, but not limited to intracranial hemorrhage or hematoma) in which most-responsible clinician deems it unsafe to augment blood pressure.\n* Untreated thyrotoxicosis\n* Acute or acute on chronic liver failure\n* Patient unable to take oral medications\n* Bradycardia with resting heart rate less than 50 beats per minute.\n* Patients on an equivalent dose of Lasix \\>= 80 mg IV BID",{"count":358,"type":22},56,[149,122],"The evidence-based pharmacologic treatments available for patients with heart failure with reduced ejection fraction (HFrEF) has been established over the last few decades of cardiovascular research. These treatments, termed Foundational Guideline-Directed-Medical Therapies (GDMT), prolong patient life, improve patient-reported symptoms, and reduce hospitalizations for heart failure. A direct effect of most medication classes encompassed within GDMT is the reduction in blood pressure due to their mechanisms of action. In addition, as patients with HFrEF become more advanced in their disease, a significant proportion develop hypotension related to pump failure and autonomic dysfunction, amongst other possible mechanisms. As a result, a significant proportion of HFrEF patients are not optimized on GDMT with hypotension as their limiting barrier that would otherwise have served to improve their heart function, heart failure symptoms, and mortality. Currently, there does not exist any evidence-based strategies to address the problem of hypotension in HFrEF patients who are not optimized on GDMT.\n\nMidodrine is an alpha-adrenergic agonist (α1-AR) that exerts its effects on peripheral venous and arteriolar vasculature to increase blood pressure. This medication has been used off-label by some clinicians in the hypotensive HFrEF population to increase blood pressure and has been reported to have beneficial effects in improving GDMT utilization as well as increasing left ventricular ejection fraction (LVEF) in published case reports\u002Fcase series. There does not exist any randomized prospective data on the use of midodrine in the hypotensive HFrEF population. The investigators' objective is to complete the first open-label, randomized control trial of midodrine in the hypotensive HFrEF population to demonstrate feasibility in performing a trial in this patient population and to show efficacy in increasing blood pressure without associated harm. The results of this trial will be used as the foundation and rationale for future studies assessing the impact of midodrine use on GDMT utilization as well as hard cardiovascular outcomes in the hypotensive HFrEF population, including hospitalizations for heart failure and mortality.",[28,362,363],"Hypotension","LV Dysfunction",[125,237,365],"Midodrine","2026-04-29",{"date":368,"type":38},"2026-04-30",{"date":324,"type":22},{"date":371,"type":22},"2028-06-01",{"name":373,"class":45},"Ottawa Heart Institute Research Corporation",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":393,"locationsCount":395},"100620074","digital-remote-management-versus-usual-care-for-optimization-of-guideline-directed-medical-therapy-in-patients-with-heart-failure-and-reduced-ejection-fraction-a-multicentre-randomised-controlled-trial-digicare-hfref-100620074","NCT07352891","Digital Remote Management Versus Usual Care for Optimization of Guideline-directed Medical Therapy in Patients With Heart Failure and Reduced Ejection Fraction: a Multicentre, Randomised, Controlled Trial (DigiCare-HFrEF)","Digital Remote Management for Care and Continuous Optimization Versus Usual Care for Optimization of Guideline-directed Medical Therapy in Patients With Heart Failure and Reduced Ejection Fraction (DigiCare-HFrEF): a Multicentre, Randomised, Controlled Trial","DigiCare-HFrEF","Inclusion Criteria:\n\n1. Adults aged ≥18 years.\n2. Hospitalised at a secondary or tertiary hospital with established heart failure care capacity.\n3. Diagnosed with HFrEF within the past 3 months according to the 2022 ACC\u002FAHA\u002FHFSA guideline diagnostic pathway, including: LVEF ≤40% by echocardiography; typical heart-failure symptoms and\u002For signs; and exclusion of non-HF causes of symptoms.\n4. Not optimized on guideline-directed medical therapy (GDMT) at enrollment, defined as at least two of the following four foundational drug classes not initiated or administered at \\\u003C50% target dose.\n5. Written informed consent provided.\n\nExclusion Criteria:\n\n1. Absolute contraindication to heart failure pharmacotherapy.\n2. History of heart transplantation or currently on a transplant waiting list.\n3. Receiving or planning implantation of a left ventricular assist device.\n4. Pregnant or breastfeeding women.\n5. Organ transplantation within the past 12 months.\n6. Unable to use the remote management platform as required (e.g., cognitive impairment or lack of caregiver support).\n7. Unable to perform blood pressure or body-weight monitoring (e.g., severe limb disability).\n8. Unable to express willingness or comply with follow-up requirements (e.g., unable to use internet-enabled devices).\n9. Any other condition judged by the investigator to make the patient unsuitable for participation.",{"count":383,"type":22},252,[25],"DigiCare-HFrEF is an investigator-initiated, multicentre, randomised, open-label, endpoint-blinded, superiority trial designed to evaluate whether a structured digital remote-management platform can optimise guideline-directed medical therapy (GDMT) in patients with heart failure with reduced ejection fraction (HFrEF) after hospital discharge. Eligible adults (≥18 years) with a confirmed diagnosis of HFrEF within the past 3 months (left ventricular ejection fraction ≤40%) who are not optimally treated with GDMT-defined as at least two of the four foundational drug classes (ACEi\u002FARB or ARNi, β-blocker, MRA, SGLT2 inhibitor) either not initiated or prescribed at \\\u003C50% of the target dose-will be randomly assigned in a 1:1 ratio to digital remote management or usual care. In the intervention arm, patients will report symptoms and key physiologic measures (e.g., blood pressure, heart rate, and body weight) via the platform; an algorithm will perform risk stratification and generate GDMT optimisation suggestions and decongestion prompts, as well as a comprehensive management for core health metrics, which are reviewed and confirmed by clinicians before implementation. The primary endpoint is the change in GDMT score from baseline to 3 months (ΔGDMT).",[28],"2026-04-21",{"date":389,"type":38},"2026-04-24",{"date":391,"type":38},"2026-02-26",{"date":72,"type":22},{"name":394,"class":45},"Beijing Anzhen Hospital",6,{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":406,"briefSummary":408,"conditions":409,"keywords":410,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":425},"100628746","phase-1-a-safety-and-tolerability-study-of-hjb647-in-heart-failure-participants-with-reduced-ejection-fraction-100628746","NCT07465653","A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction","A Multi-center, Randomized, Participant- and Investigator- Blinded, Placebo-controlled Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of HJB647 in Participants With Chronic Stable Heart Failure With Reduced Ejection Fraction","Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria:\n\n* Men and women aged 18 years or older\n* Stable NYHA functional class II-III\n* LVEF \\\u003C50%\n* NT-proBNP ≥600 pg\u002Fml if in sinus rhythm or ≥900 pg\u002Fml if in atrial fibrillation at screening\n* On stable standard of care therapy with sacubitril\u002Fvalsartan with a dose of at least 49\u002F51 mg BID for at least 4 weeks before screening.\n\nExclusion Criteria:\n\nParticipants will be deemed ineligible for inclusion if they meet any of the following exclusion criteria:\n\n* Acute decompensated heart failure within 3 months prior to screening\n* SBP \\\u003C105 mmHg at screening or baseline.\n* Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, PCI, or carotid angioplasty within the 6 months prior to screening\n* Hemodynamically significant mitral and\u002For aortic valve disease, or any prior valve replacement, except mitral regurgitation secondary to LV dilation at screening\n* eGFR \\\u003C45 ml\u002Fmin\u002F1.73m2 at screening, as measured by the CKD-EPI formula\n* BMI \\>40 kg\u002Fm2\n* Strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products\n* Women of childbearing potential\n\nFurther eligibility criteria might apply in alignment with the trial protocol.","100 Years",{"count":405,"type":22},12,[407],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF\u002FHFmrEF).",[28],[411,412,30,413,414,415],"Sacubitril","Valsartan","Cardiac Failure","Myocardial Failure","Heart failure with reduced ejection fraction","2026-04-10",{"date":418,"type":38},"2026-04-15",{"date":420,"type":38},"2026-03-18",{"date":422,"type":22},"2026-09-24",{"name":424,"class":138},"Novartis Pharmaceuticals",3,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":23,"phases":436,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":447,"leadSponsor":449,"locationsCount":77},"100558555","synchronized-diaphragmatic-stimulation-in-symptomatic-heart-failure-100558555","NCT06552637","Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure","RECOVER-HF - RandomizEd, Multi-Center, Double-Blinded Study of SynchrOnized Diaphragmatic Stimulation (SDS) for ImproVEment of Symptomatic Reduced Ejection Fraction Heart Failure","RECOVER-HF","Inclusion Criteria:\n\n* NYHA classes II\u002FIII on optimal Guideline Directed Medical Therapy (GDMT)\n* QRS duration ≤ 130 ms\n* EF≤ 40%\n\nExclusion Criteria:\n\n* Baseline 6 minute walk test \\> 500 meters or \\\u003C 200 meters\n* NT-proBNP\\\u003C 250 if on loop diuretics, or NT-proBNP \\\u003C 500 if not on loop diuretics\n* Supine resting heart rate \\> 140 bpm\n* Systolic blood pressure \\\u003C 80 mmHg or \\> 170 mmHg\n* Serum creatinine \\> 2.5 mg\u002FdL\n* Serum hepatic function 3x ULN\n* Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA\u002FTIA, persistent AF (\\> 24 hours), symptomatic NSVT or DCCV\n* Any inotropic drug treatment within the previous 3 months\n* Bradycardia (heart rate \\\u003C 50 beats\u002Fmin), atrial arrhythmias with rates \\> 100 beats\u002Fmin, sustained ventricular tachycardia or frequent ventricular ectopy \\>10% present during screening\n* Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy \\> 10% documented within the previous 3 months\n* Reversible non-ischemic cardiomyopathy\n* Valvular disease requiring intervention within the next 12 months or presence of significant valve disease as determined 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 mild tricuspid valve stenosis\n  4. Greater than moderate-severe tricuspid valve regurgitation\n  5. Greater than moderate aortic stenosis\n  6. Greater than moderate aortic regurgitation\n  7. Greater than mild-moderate pulmonic stenosis\n  8. Greater than moderate pulmonic regurgitation\n* Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys \\>70 mmHg at rest\n* Severe COPD, other respiratory or lung diseases where FEV \\\u003C 50%\n* Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months\n* Known history of diaphragmatic paralysis or suspicion confirmed by unilateral or bilateral elevation of the diaphragm on chest x-ray\n* Pericardial disease\n* Diabetic neuropathy\n* Existing diaphragmatic stimulation for respiration assist\n* Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months); or CRT that is indicated or implanted and functional\n* Contraindications to laparoscopic access to the diaphragm, as determined by the implanting physician\n* Known intra-abdominal pathology which could increase the risk of laparoscopic access to the diaphragm.\n* Previous open laparotomy within 1 year\n* Previous thoracic or abdominal organ transplant\n* Drug induced immuno-suppression\n* Body mass index \\> 40\n* Enrollment in a concurrent investigation \u002F clinical study\n* Having a life expectancy of \\\u003C1 year due to any condition\n* Pregnant or planning a pregnancy during the study period\n* Known allergies to implantable device materials\n* History of systemic infection requiring the use of intravenous antibiotics within the previous 3 months",{"count":435,"type":22},270,[25],"RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.",[28],[125,440,441,442],"Heart Disease","Synchronized Diaphragmatic Stimulation","Implantable Heart Failure Device Therapy","2026-03-27",{"date":445,"type":38},"2026-03-31",{"date":368,"type":22},{"date":448,"type":22},"2029-12",{"name":450,"class":138},"VisCardia Inc.",{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":118,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":470,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":4},"100609422","a-randomized-placebo-procedure-controlled-trial-of-the-enhancor-system-pulmonary-artery-denervation-to-evaluate-safety-and-efficacy-in-patients-with-combined-pre--and-post-capillary-pulmonary-hypertension-associated-with-left-heart-disease-100609422","NCT07214376","A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease","A Randomized Placebo-procedure Controlled Trial of the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System PULmonary Artery Denervation Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease","The PULSE-LHD","Inclusion Criteria:\n\n1. Subject is ≥18 and ≤85 years of age\n2. Subject is diagnosed with chronic HF due to left-sided heart disease for at least 6 months prior to screening (regardless of LVEF), and remains symptomatic despite maximally tolerated class I GDMT for left heart failure and CRT as appropriate per US or EU guidelines according to region of enrollment\n3. Subject is clinically stable, defined as:\n\n   * No hospitalizations for heart failure for at least 1 month; no major changes in societal guideline-recommended class I oral GDMT for left heart failure for at least 1 month; no CRT or ICD implant in the prior 3 months; and no anticipated major changes in any HF-GDMT (other than possibly diuretic dose) or planned cardiac rhythm management device implantation after the procedure\n   * SBP is ≥90 and ≤160 mmHg and resting HR is ≥50 and ≤100 bpm (≤110 bpm for atrial fibrillation)\n4. PASP (RVSP) is ≥30 mmHg on the baseline TTE.\n5. Subject has New York Heart Association (NYHA) class II, III or IVa symptoms (IVa is defined as symptoms with minimal exertion or at rest, but the patient is able to ambulate and does not require continuous intravenous medications).\n6. Subject has 6MWD at baseline ranging from 100 to 450 m limited by dyspnea or fatigue and not orthopedic or other non-HF-related issues\n7. Subject has NT-proBNP ≥600 pg\u002FmL for patients with LVEF ≤40% or ≥200 pg\u002FmL for patients with LVEF \\>40% at the time of screening (a central lab will be made available for sites that cannot measure NT-proBNP)\n8. Subject is able and willing to follow all aspects of the research protocol including medication compliance and follow-up visits and testing.\n9. Subject or the subject's legally designated representative signs an IRB\u002FEC approved informed consent form prior to study participation.\n\nExclusion Criteria:\n\n1. Subject has a life expectancy of less than 1 year due to non-cardiovascular causes.\n2. Subject has known hypertrophic cardiomyopathy with either left ventricular (LV) outflow tract obstruction or systolic anterior motion (SAM) of the anterior leaflet of the mitral valve; pericardial disease; or infiltrative or active inflammatory myocardial disease, including known amyloidosis\n3. Subject has severe stenosis or regurgitation of any heart valve, moderate or severe stenosis of the aortic valve, or any degree of stenosis of the pulmonic valve\n4. Subject has symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke in the prior 30 days or any prior stroke with a permanent residual deficit with modified Rankin Scale (mRS) score ≥4\n5. Subject has any prior intracranial hemorrhage with or without a residual deficit, or any known intracranial pathology pre-disposing to bleeding (e.g. mass, AV fistula, aneurysm, etc.)\n6. Subjects with a known bleeding diathesis or who will refuse blood transfusions\n7. Subjects allergic to heparin (including heparin induced thrombocytopenia), unless bivalirudin or argatroban can be used for procedural anticoagulation\n8. Subjects with life threatening allergy to contrast dye that cannot be adequately pre-medicated, or any prior contrast-related anaphylaxis\n9. Subject has congenital heart disease other than mitral valve prolapse or a PFO\n10. Subject had coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in the prior 6 months or is anticipated to undergo CABG or PCI within 12 months after randomization.\n11. Subject has any pacemaker with an intracardiac sensing or pacing lead or wire implanted in the prior 3 months, or CardioMEMS HF System or other intracardiac pressure monitoring system, or cardiac contractility modulation system or baroreceptor activation therapy implanted within the prior 3 months, or any plans to implant any of these devices within 12 months after the procedure.\n12. Subject has undergone atrial fibrillation ablation within the prior 6 months or is anticipated to undergo atrial fibrillation ablation within 12 months after randomization.\n13. Subject has undergone heart valve surgery or transcatheter valve intervention within the prior 6 months or is anticipated to undergo heart valve surgery or transcatheter valve intervention (e.g., valve repair or replacement, valvuloplasty) within 12 months after randomization.\n14. Subject has any tricuspid or pulmonic valve implants (implanted annuloplasty rings are allowed).\n15. Subject has an inferior vena cava (IVC) filter implant.\n16. Subject has received a prior heart or heart-lung transplantation or is listed for heart or heart-lung transplantation or is anticipated to receive a ventricular assist device (VAD) implant within 6 months after randomization.\n17. Subjects with intracardiac thrombus on TTE.\n18. Subjects with pericardial effusion ≥10 mm on TTE\n19. Subject's PH is predominantly due to WHO Group 1, 3, 4, or 5. Note: Multifactorial features of PH may be present, but the predominant diagnosis must be WHO Group 2 CpcPH.\n20. Subject has been treated with any group 1 PAH-targeted drugs, including sotatercept, within the prior month or is planned to receive such therapy after randomization.\n21. Subject is anticipated to undergo any surgery within 6 months after randomization (other than minor surgeries requiring only local anesthesia).\n22. Subject has severe renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2 by the CKD-EPI formula, or on dialysis).\n23. Subject has severe liver insufficiency (Child-Pugh classification C).\n24. Subject has platelet count \\\u003C100 × 109\u002FL.\n25. Subject has systemic inflammatory or other disease requiring long-term use of oral glucocorticoids or immunosuppressants.\n26. Subject has active infection requiring oral or intravenous antibiotics.\n27. Subject has a body mass index (BMI) \\>45 kg\u002Fm².\n28. Subjects with severe respiratory disease, defined as any disorder of the respiratory system with diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C40% AND total lung capacity (TLC) \\\u003C60% AND forced expiratory volume in one second (FEV1) \\\u003C70% by plethysmography; OR who require ambulatory or long-term oxygen therapy\n29. Subject has known severe untreated sleep apnea. Note: Subjects with sleep apnea treated with CPAP\u002FBiPAP for at least the prior 3 months are not excluded.\n30. Subjects with pulmonary embolism or deep vein thrombosis in the prior 6 months.\n31. Subject is a pregnant or breastfeeding woman, or a woman planning to become pregnant within one year. Women of child-bearing potential must have a negative pregnancy test within 1 week of randomization.\n32. Subject is participating in another clinical trial of an investigational drug or device that has not reached its primary endpoint.\n33. Subject has severe cachexia\u002Ffrailty, substance abuse, or any other condition that the investigator believes may affect the subject's ability to comply with or complete all the study requirements including follow-up visits.\n34. Subject is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, children, impoverished persons, persons in prisons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations may also include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.",{"count":460,"type":22},750,[25],"The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.)\n\nParticipants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.",[464,28,465,466,467,125,468,469],"Pulmonary Hypertension","Hypertension","Vascular Diseases","Cardiovascular Diseases","Heart Failure With Preserved Ejection Fraction","Heart Failure With Mid Range Ejection Fraction",[471,472,125,473,474],"Pulmonary Artery Denervation","Pulmonary Hypertension Due to Left Heart Disease","pulmonary hypertension","left heart failure","2026-03-11",{"date":477,"type":38},"2026-03-12",{"date":479,"type":22},"2026-04-01",{"date":481,"type":22},"2031-12-31",{"name":483,"class":138},"Pulnovo Medical, Inc.",{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":492,"targetDuration":494,"studyType":205,"phases":4,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":77},"100380754","real-time-monitoring-of-heart-failure-across-the-yale-new-haven-health-system-100380754","NCT04237701","Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System","Retrospective and Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System Via a Live Registry","Yale-HF","Inclusion Criteria:\n\n* Seen within the Yale New Haven Health System\n* Diagnosis of heart failure\n\nExclusion Criteria:\n\n* Age\\\u003C18",{"count":493,"type":22},40000,"10 Years","The Yale HF Registry is a live EHR based registry that allows for retrospective and real-time monitoring of Heart Failure case across the Yale New Haven Health System.",[125,28,468,497],"Heart Failure NYHA Class IV","2026-03-02",{"date":500,"type":38},"2026-03-05",{"date":502,"type":38},"2019-10-01",{"date":504,"type":22},"2030-12-30",{"name":506,"class":45},"Yale University",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":77},"100614156","digital-support-program-for-patients-with-heart-failure---a-cluster-randomized-hybrid-type-2-study-100614156","NCT07275931","Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study","Digital Support Program Via 1177 for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study for Evaluation of Effects and Implementation","Inclusion criteria:\n\n* Diagnosed with heart failure with reduced ejection fraction (HFrEF) or heart failure with midrange reduced ejection fraction (HFmrEF) (ejection fraction ≤50%) verified by echocardiography or Magnetic Resonance Imaging\n* Access to BankID, a computer, tablet, or smartphone\n* Aged ≥18 years\n* Able to understand and communicate in Swedish\n* Provided informed consent\n\nExclusion criteria:\n\n* Barriers to participation (e.g., not Swedish-speaking, cognitive impairment, severe mental illness, substance abuse)\n* Life expectancy of less than six months",{"count":515,"type":22},240,[25],"The overall aim of this project is to evaluate the effects of a digital support program for patients with heart failure through a cluster-randomized controlled trial, and to investigate the outcomes of different implementation strategies using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), PRISM (Practical, Robust Implementation and Sustainability Model) and ERIC (Expert Recommendations for Implementing Change) framework.\n\nOur primary hypothesis is that the digital support program will improve patients' perceived control over their heart failure, measured with the validated Control Attitude Scale.\n\nSecondary hypotheses are that the program will increase patients' health-related quality of life, self-care behaviors, heart failure knowledge, perceived continuity of care, and participation in care, and reduce symptoms of depression.\n\nImplementation aim (based on the RE-AIM, PRISM and ERIC frameworks) The implementation component of the study aims to compare two different implementation strategies: a standard (basic) support package versus a tailored, context-specific support strategy.\n\nHeart failure clinics at hospitals an within primary care will be matched and randomized into two arms. The intervention arm will receive tailored implementation support to implement the support program. The control arm will recive implementation support according to a predefined standard procedure.\n\nResearchers will compare the intervention arm with control arm to see if there are any differences regarding the implementationsuccess between the arms.\n\nThe patients in both arms will have access to the support program during six months.",[28],[520,521,522,523,524,525,526],"Co-design","E-health","support","implementation","RE-AIM","PRISM","ERIC","2026-02-24",{"date":529,"type":38},"2026-02-27",{"date":531,"type":38},"2025-12-15",{"date":533,"type":22},"2029-06-30",{"name":535,"class":536},"Linkoeping University","OTHER_GOV",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":77},"100525995","phase-2-withdrawal-of-treatment-for-heart-failure-patients-with-recovery-from-tachycardia-induced-cardiomyopathy-100525995","NCT06128980","Withdrawal of Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy","Withdrawal of Pharmacological Treatment for Heart Failure Patients With Recovery From Tachycardia-induced Cardiomyopathy - WEAN-HF","WEAN-HF","Inclusion Criteria:\n\nPatients with new onset heart failure (ambulatory or hospital) with reduced ejection fraction (LVEF≤40% assessed by echocardiography) and NYHA ≥2 and atrial fibrillation or atrial flutter with ventricular rate ≥110 bpm (ECG monitoring, hospital telemetry or Holter monitoring) that following GDMT - while AF is terminated (e.g. ablation or conversion) or controlled (HR\\\u003C110 on resting ECG) - experience LVEF remission (LVEF ≥50%), normalization of indexed LV volume, and normal ECG (no bundle branch block, ST segment deviations or T-wave inversion) and NT-proBNP \\\u003C250 pg\u002Fml.\n\nExclusion Criteria:\n\n* 18 years or older and able to consent\n* Former ablation procedures and inability to tolerate antiarrhythmic drugs\n* Pregnancy\n* Congenital heart disease (congenital defects with no hemodyamic effects are not excluded)\n* Previously genotyped positive for genes known to cause cardiomyopathy\n* Probable hypertrophic, restrictive or non-compaction cardiomyopathy\n* Moderate\u002Fsevere valvular disease\n* Suspicion of or known cardiac amyloidosis, sarcoidosis, or other storage\u002Finflammatory disease\n* More than 10% PVCs or documented sustained ventricular arrhythmias\n* History of persistent or permanent AF with ventricular rates \\>110 before incident HF despite best standard of care\n* eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n* Acute myocardial infarction at index\n* Probable medication-, alcohol- or illicit drug use induced AF and\u002For HF\n* Systolic blood pressure \\>160 mmHg (at multiple measurements) at index or history of uncontrollable hypertension\n* Myocarditis\n* Cardiogenic shock at index\n* Aborted sudden cardiac death\n* Pacing-induced cardiomyopathy\n* 1.st degree relative with DCM",{"count":546,"type":22},348,[149,122],"New onset heart failure (HF) is observed in up to 25% of patients with incident atrial fibrillation or flutter (AF). Current guidelines suggest that both conditions (AF \\& HF) be addressed with guideline directed medical therapy (GDMT) for HF and rate or rhythm control of AF. Hence, patients with both conditions are subjected to extensive polypharmacy with possible prognostic benefits, but also possible side effects, such as decreased renal function, dizziness, tiredness and hypotension, as well as the financial burden on both the individual patients and society, in addition to the stigma of having a HF diagnosis.\n\nGuidelines do not inform how to manage long-term patients with HF, who following control of the incident tachycardia (e.g. AF), show full recovery from their HF condition.\n\nThis investigator-initiated, open-label, randomized, non-inferiority trial will test whether incremental weaning of GDMT in patients following full cardiac recovery and AF control is non-inferior compared to continuous GDMT with respect to the primary endpoint of freedom from heart failure deterioration. Furthermore, this study seeks to extensively phenotype these patients (genetic testing, advanced imaging, biomarkers etc.) in order to establish whether certain phenotypes are at lesser or greater risk of deterioration once remission is established. This novel approach of a personalized treatment regimen depending on e.g. genetic profiling could lead to an aggressive treatment in patients at high risk of deterioration and conversely spare patients with a negligible risk, a life-long intensive treatment regimen.\n\nAll HF clinics located in Zealand, Denmark, with a catchment area of \\>2 million citizens, have agreed to participate in the WEAN-HF trial. A total of 348 patients will be randomized. Patients are followed up the 1st year after randomization with clinical examination, biomarkers and echocardiography, and are subsequently followed via Danish nationwide registries for 10 years.",[28,550],"Heart Rhythm Disorder","2026-02-20",{"date":553,"type":38},"2026-02-23",{"date":555,"type":38},"2025-01-09",{"date":557,"type":22},"2032-01",{"name":559,"class":45},"Herlev and Gentofte Hospital",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":567,"enrollmentInfo":568,"targetDuration":4,"studyType":23,"phases":570,"briefSummary":572,"conditions":573,"keywords":575,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":77},"100533735","early-phase-1-ketones-sglt2-hfref-100533735","NCT06229678","Ketones, SGLT2, HFrEF","Ketones, Muscle Metabolism, and SGLT2 Inhibitors","Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \\\u003C50%\n* Age 18-80 years\n* BMI 23-44 kg\u002Fm2\n* Glycated hemoglobin (HbA1c) 6.0-10.0%\n* Blood Pressure (BP) ≤ 145\u002F85 mmHg\n* Estimated glomerular filtration rate (eGFR) ≥30 ml\u002Fmin•1.73 m2\n* Only Type 2 diabetics treated with diet\u002Fexercise, metformin, sulfonylureas, metformin\u002Fsulfonylurea, Glucagon-like peptide-1 receptor agonist (GLP-1 RA), or insulin\n* Stable body weight (±4 pounds) over the previous 3 months prior to enrollment\n* Ability to understand study procedures and to comply with them for the entire length of the study.\n\nExclusion Criteria:\n\n* Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, hypertrophic obstructive cardiomyopathy.\n* Significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose or addition of another heart failure medication)\n* Type 2 Diabetics treated with Dipeptidyl Peptidase-4 Inhibitor (DPP4i) or pioglitazone\n* Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each MRI study to assess current status. For women of child-bearing age (WOCBA) willingness to use contraception, if applicable.\n* Allergy\u002Fsensitivity to study drugs or their ingredients.\n* Cancer.\n* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent.","70 Years",{"count":569,"type":22},71,[571],"EARLY_PHASE1","The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function",[574,28],"Type2diabetes",[576,577],"ketones","cardiovascular benefit","2026-02-03",{"date":580,"type":38},"2026-02-05",{"date":582,"type":38},"2024-01-25",{"date":584,"type":22},"2027-03-01",{"name":586,"class":45},"The University of Texas Health Science Center at San Antonio",{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":86,"enrollmentInfo":594,"targetDuration":4,"studyType":205,"phases":4,"briefSummary":595,"conditions":596,"keywords":598,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":77},"100539099","hemodynamic-assessment-of-underlying-myocyte-function-in-right-heart-failure-100539099","NCT06299436","Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure","HALT-RHF","Inclusion Criteria:\n\n* Adult patients aged between 18 and 90 years of age\n* Diagnosed with heart failure with reduced ejection fraction (LV ejection fraction ≤ 40-50%)\n* Can safely hold direct oral anticoagulant (DOAC) vitamin K antagonist (VKA) for 48 hours prior to the procedure\n\nExclusion Criteria:\n\n* Unable to interrupt VKA anticoagulation\n* Point of care International Normalized Ratio (INR) \\> 1.5\n* Pregnant patients\n* Acute hospitalization or decompensation within 2 weeks prior to study date\n* Participation in a study involving an investigational drug within 4 weeks prior to study date\n* Inability to lie flat in the supine position\n* Symptomatic hemodynamic instability at rest or during the procedure",{"count":257,"type":22},"Right ventricular (RV) failure is recognized to worsen patient outcomes in the setting of heart failure with reduced ejection fraction (HFrEF)-related pulmonary hypertension (PH), yet the investigators fall short in trying to identify and treat it. The current proposal will (1) determine the best clinical indicators of intrinsic RV myocyte contractile failure in humans with HFrEF-PH, (2) clarify underlying mechanisms, and (3) test novel treatments on RV myocytes. The long-term goal of this proposal will be to better identify and treat RV failure in humans suffering from HFrEF-PH.",[28,464,597],"Right Heart Failure Due to Left Heart Failure",[599,290,600,473,601],"right heart failure","cardiomyopathy","heart failure with reduced ejection fraction","2026-01-09",{"date":604,"type":38},"2026-01-12",{"date":606,"type":38},"2024-12-10",{"date":608,"type":22},"2029-03-31",{"name":610,"class":45},"Johns Hopkins University",{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":619,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":620,"targetDuration":622,"studyType":205,"phases":4,"briefSummary":623,"conditions":624,"keywords":628,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":77},"100322647","biomechanical-precision-medicine-registry-for-patients-with-and-without-heart-failure-100322647","NCT03480633","Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure","Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study","PREFER-HF","Inclusion criteria for patients with HF:\n\n* 18 years and older\n* History of clinical symptoms consistent with HF and at least one of the following supporting evidence of HF:\n\n  * NT-proBNP \\> 125 pg\u002FmL\n  * BNP \\> 35 pg\u002FmL\n  * Capillary wedge pressure ≥ 15 mmHg on right heart catheterization or CI \\\u003C2.8 L\u002Fmin\u002Fm2\n  * LVEDP ≥ 15 mmHg\n  * Radiographic evidence of pulmonary edema\n  * Improvement in symptoms with diuretic initiation of increase\n  * CPET evidence of cardiac etiology of symptoms\n\nHFpEF: LVEF ≥ 50% HFrEF: LVEF \\\u003C50%\n\nExclusion criteria (for all patients, including both those with HFpEF and HFrEF):\n\n\\- End stage renal disease on dialysis",true,{"count":621,"type":22},3000,"50 Months","In this single-center, longitudinal observational study, we will comprehensively examine clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand how different heart failure types may develop and progress over time. We will evaluate distinct sub-groups of heart failure (also known as heart failure phenotypes) and cardiomyopathies including amyloidosis with an ultimate goal of bringing the right medications and therapy to the right patients to optimize benefit and minimized side effects, an effort to improve precision medicine in heart failure.",[625,28,626,469,627],"Heart Failure With Normal Ejection Fraction","Heart Failure, Right Sided","Cardiovascular Risk Factor",[30,629,630,631,632,633,634],"Precision medicine","High risk patients","Pathophysiology","Bioregistry","Biomarkers","Heart failure etiology","2025-12-02",{"date":637,"type":38},"2025-12-09",{"date":639,"type":38},"2016-04-07",{"date":641,"type":22},"2027-10-06",{"name":643,"class":45},"Massachusetts General Hospital",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":23,"phases":654,"briefSummary":655,"conditions":656,"keywords":657,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":77},"100588501","digital-solutions-in-heart-therapy-dignity-100588501","NCT06942221","Digital Solutions in Heart Therapy (DIGNITY)","Digital Solutions in Heart Therapy (DIGNITY) - a Randomized Controlled Trial Using Telemedicine for Heart Failure Treatment","DIGNITY - HF","Inclusion Criteria:\n\n1. Age \\> 18 years at the time of hospital admission\n2. Ability to use a (smart)phone and\u002For tablet for the follow-up\n3. Documented left ventricular ejection fraction (LVEF) \\> 40% assessed within preceding 12 months\n4. Not treated with optimal doses of oral HF therapies within 2 days before anticipated hospital discharge for acute HF in at least one of the medication categories (for details see Table 1 on page 10)\n5. Hospitalized due to acute HF decompensation.\n6. Specific measures within 24 hours prior to randomization\n\n   * Systolic blood pressure \\> 100 mmHg, and heart rate \\> 60bpm\n   * Serum potassium \\\u003C 5mmol\u002FL\n\nExclusion Criteria:\n\n1. Inability to use a (smart)phone or tablet\n2. Clear intolerance to high doses of betablockers, ACE inhibitors, or ARBs\n3. Estimated glomerular filtration rate \\\u003C30ml\u002Fmin\u002F1.73m2 or dialysis\n4. Myocardial infarction, unstable angina or cardiac surgery within 3 months, percutaneous transluminal coronary intervention within 1 months prior to screening\n5. Cardiac resynchronization therapy device implantation within 3 months prior to screening\n6. Presence of significant obstructive lesion of the left ventricular outflow tract\n7. Amyloid cardiomyopathy\n8. Participation in other clinical trials for drugs\n9. Pregnant or nursing women\n10. Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception",{"count":653,"type":22},140,[25],"This study aims to assess the safety and effectiveness of telemedicine guided strategy on guideline-directed medical therapy (GDMT) optimization in hospitalized patients with heart failure in comparison to usual care in Switzerland.",[28],[658,659],"guideline-directed medical therapy","telemedicine","2025-12-01",{"date":635,"type":38},{"date":663,"type":38},"2025-07-17",{"date":665,"type":22},"2026-12-31",{"name":667,"class":45},"University Hospital, Basel, Switzerland",{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":672,"acronym":673,"eligibilityCriteria":674,"healthyVolunteers":12,"sex":18,"minAge":171,"maxAge":4,"enrollmentInfo":675,"targetDuration":4,"studyType":23,"phases":677,"briefSummary":678,"conditions":679,"keywords":681,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":691,"completionDateStruct":692,"leadSponsor":694,"locationsCount":4},"100611274","phase-4-optimising-pacing-therapy-integrated-medical-therapy-and-catheter-ablation-for-atrial-fibrillation-in-heart-failure-trial-100611274","NCT07238452","Optimising Pacing Therapy, Integrated Medical Therapy, and Catheter AbLation for Atrial Fibrillation in Heart Failure Trial","OPTIMAL AF-HF","Inclusion Criteria:\n\n* Age of 18 years or older on the date of Informed Consent,\n* Atrial fibrillation,\n* Left ventricular ejection fraction of 40% or less, measured within 6 months of enrollment,\n* Receiving stable foundational HF quadruple therapy at maximally tolerated dose,\n* BNP ≥ 100 pg\u002FmL (NT-proBNP ≥ 400 pg\u002Fml), measured within 1 month of randomisation.\n\nExclusion Criteria:\n\n* Anticipated life expectancy less than one year from the consent date,\n* Continuous atrial fibrillation of \\>1 year in duration,\n* Left atrial anteroposterior diameter \\> 6 cm, volume \\> 100 mL, or volume index \\> 60 mL\u002Fm2,\n* Previous left atrial ablation or left atrial surgery,\n* The presence of a percutaneous left atrial appendage closure device,\n* Uncontrolled hypo- or hyperthyroidism,\n* Subject known to be pregnant or breast-feeding,\n* Contraindication to oral anticoagulation therapy,\n* Left atrial myxoma,\n* Myocardial infarction or percutaneous coronary intervention within 3-months of consent,\n* History of, or anticipated to undergo heart transplant, ventricular assist device insertion, or mitral or tricuspid valve repair or replacement within 3-months of the consent date.",{"count":676,"type":22},1056,[57],"Atrial Fibrillation (AF) and Heart Failure (HF) are colliding global cardiovascular epidemics, individually impairing quality of life and cardiac performance, as well as increasing the risk of hospitalisation and mortality. When AF and HF co-exist, disease progression accelerates and the adverse outcomes are magnified, leading to incrementally higher morbidity, mortality, and healthcare expenditure. The management of AF has been dichotomised into the restoration and maintenance of sinus rhythm (\"Rhythm control\") or acceptance of AF with control of the ventricular response (\"Rate control\"). Previous studies suggested that pharmacologic rhythm control and pharmacologic rate control confer similar survival and morbidity outcomes in patients with significant left ventricular dysfunction. Recognising the limitations of pharmacotherapy, more recent studies have examined the utility of catheter ablation procedures, either designed to restore and maintain sinus rhythm (e.g., catheter-based pulmonary vein isolation) or control the ventricular response (e.g., pacemaker implantation in combination with catheter ablation of the atrioventricular junction). Compared to pharmacotherapy, these studies have suggested that catheter ablation may provide sustained improvements in quality of life, decreased hospitalisation and, potentially, improved survival for patients with co-existing AF and HF. However, these studies were performed prior to the modern era of quadruple LV enhancing therapy (beta-blocker, an angiotensin receptor-neprilysin inhibitor, mineralocorticoid receptor antagonist, and an SGLT2 inhibitor). The true impact of catheter-based interventions, and thus the optimal management of AF for patients with co-existing HF is not known. The investigators propose a randomised controlled trial to definitively answer the question regarding the optimal invasive treatment of AF in patients with heart failure with reduced ejection fraction (HFrEF - LVEF ≤ 40%).",[28,680],"Atrial Fibrillation (AF)",[682,290,600,683,684,685,686,687],"Atrial fibrillation","catheter ablation","pulsed field ablation","atrioventricular node ablation","conduction system pacing","cardiac resyncronization therapy","2025-11-21",{"date":690,"type":38},"2025-11-28",{"date":660,"type":22},{"date":693,"type":22},"2033-01-01",{"name":695,"class":45},"University of British Columbia"]