[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cytokinetics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100572692","phase-3-study-with-omecamtiv-mecarbil-ck-1827452-to-treat-chronic-heart-failure-with-severely-reduced-ejection-fraction-100572692",false,"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","ALL","18 Years","85 Years",{"count":21,"type":22},1800,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Heart Failure","Heart Failure With Reduced Ejection Fraction",[31,32],"CK-1827452","omecamtiv mecarbil","RECRUITING","2026-06-23",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2024-12-19",{"date":41,"type":22},"2027-12",{"name":43,"class":44},"Cytokinetics","INDUSTRY",188,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100577059","phase-2-amber-hfpef-assessment-of-ck-4021586-in-a-multi-center-blinded-evaluation-of-safety-and-tolerability-results-in-hfpef-100577059","NCT06793371","AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF","A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-4021586 in Adults With Symptomatic Heart Failure With Preserved Ejection Fraction","AMBER-HFpEF","Inclusion Criteria:\n\n* Males and females ≥ 40 years and ≤ 85 years of age at screening.\n* Diagnosed with HF with NYHA functional class II or III.\n* Screening echocardiography with LVEF ≥ 60%.\n* Screening NT-proBNP ≥ 300 pg\u002FmL for participants in sinus rhythm and ≥ 900 pg\u002FmL for participants with comorbid atrial fibrillation or flutter.\n* Body mass index \\\u003C 40 kg\u002Fm2.\n* Participants on beta-blockers, angiotensin-converting enzyme (ACE)\u002Fangiotensin II receptor blocker (ARB) or angiotensin receptor\u002Fneprilysin inhibitor (ARNI), must be on stable doses for more than 30 days prior to screening.\n* Participants on a glucagon-like peptide-1 (GLP-1) agonist must be on a stable dose for more than 24 weeks prior to screening with no anticipated plans to change dose during this study.\n\nExclusion Criteria:\n\n* History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","40 Years",{"count":56,"type":22},60,[58],"PHASE2","This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.",[61],"Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)",[63,64,65,66,67,52,68,69,70,71,72],"Symptomatic heart failure with preserved ejection fraction","HFpEF","Heart failure","CK-4021586","CK-586","AMBER","Cardiac myosin inhibitor","CMI","CY 9021","ulacamten","2026-05-27",{"date":75,"type":37},"2026-05-29",{"date":77,"type":37},"2025-02-06",{"date":79,"type":22},"2026-09",{"name":43,"class":44},25,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100547799","phase-2-a-study-to-evaluate-the-effect-of-aficamten-in-pediatric-patients-with-symptomatic-obstructive-hypertrophic-cardiomyopathy-ohcm-100547799","NCT06412666","A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).","A Phase 2\u002F3 Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Trial to Evaluate the Efficacy and Safety of Aficamten in a Pediatric Population With Symptomatic Obstructive Hypertrophic Cardiomyopathy","CEDAR-HCM","Inclusion Criteria:\n\n* Period 1: Treatment Period\n\n  * Males and females between 12 and \\\u003C 18 years of age at screening and at Day 1.\n  * Body weight ≥ 45 kg for the initial cohort and then body weight ≥ 35 kg after at least 10 participants in the initial cohort have undergone dose titration up to Week 4 without observed events of LVEF \\\u003C 50% at the starting dose of 5 mg qd.\n  * Core laboratory confirmation of the following oHCM echocardiographic criteria at screening:\n* Left ventricular (LV) hypertrophy with nondilated LV chamber in the absence of other cardiac disease.\n* LV end-diastolic wall thickness that meets a threshold of:\n\n  * Z-score \\> 2.5 in the absence of family history OR\n  * Z-score \\> 2 in the presence of positive family history or positive genetic test.\n* LVEF ≥ 60% AND Valsalva LVOT-G ≥ 50 mmHg.\n\n  * oHCM of sarcomeric origin confirmed by genetic testing or, if unable to confirm by genetic testing, oHCM of sarcomeric origin may be presumed in the absence of history of metabolic disorders, mitochondrial cardiomyopathies, neuromuscular disease, malformation syndromes, infiltrative diseases\u002Finflammation, and endocrine disorders (such as Fabry's disease, Noonan syndrome with left ventricular hypertrophy, and amyloid-cardiomyopathy).\n  * New York Heart Association (NYHA) Class ≥ II at screening.\n  * Adequate acoustic windows for echocardiography.\n  * Participants on beta blockers, verapamil, diltiazem, or disopyramide should have been on stable doses for more than 4 weeks prior to randomization.\n* Period 2: Open-Label Extension\n\n  * Completed Period 1. If unable to complete Period 1 due to circumstances not related to compliance or safety, the Medical Monitor may review and determine eligibility.\n  * LVEF ≥ 55% after washout.\n* Period 3: Long-term Extension • Completed Period 2.\n\nExclusion Criteria:\n\n* Period 1: Treatment Period\n\nAny of the following criteria will exclude potential participants from the trial:\n\n* Significant valvular heart disease.\n\n  * Moderate or severe valvular aortic stenosis or fixed subaortic obstruction.\n  * Mitral regurgitation that is greater than mild in severity and not due to systolic anterior motion of the mitral valve (per judgment of Principal Investigator or designee).\n  * Evidence of fixed left-sided obstruction (eg, subaortic membrane, aortic valve stenosis, or coarctation of the aorta).\n* History of LV systolic dysfunction (LVEF \\\u003C 45%) or stress cardiomyopathy at any time during their clinical course.\n* History of congenital heart disease other than oHCM (may be enrolled if not hemodynamically significant in the judgement of the Principal Investigator and study Medical Monitor).\n* Has been treated with SRT (surgical myectomy or percutaneous alcohol septal ablation) within the preceding 6 months or has plans for either treatment during the trial period.\n* History of paroxysmal or persistent atrial fibrillation or atrial flutter.\n* History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia within 3 months prior to screening.\n* History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the Principal Investigator (or designee) or the Medical Monitor, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.\n* Current or previous use of drugs known to cause cardiomyopathy (eg, anthracyclines, monoclonal antibodies \\[trastuzumab\\], alkylating agents \\[cyclophosphamide\\], and tyrosine kinase inhibitors \\[sunitinib and imatinib\\]).\n* Currently participating in another investigational device or drug trial or received an investigational device or drug \\\u003C 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening.\n* Implantable cardioverter defibrillator (ICD) implantation within 6 weeks of screening or planned ICD implantation during the trial period.\n* Has received prior treatment with aficamten or mavacamten.\n* Currently listed for heart transplantation or anticipated to be listed for heart transplantation in the next 12 months.","12 Years","17 Years",{"count":93,"type":22},55,[58,25],"The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).",[97,98],"Pediatric","Symptomatic Obstructive Hypertrophic Cardiomyopathy",[100,101,102,98,103,104,88,105],"CK-3773274","CK-274","Aficamten","oHCM","CEDAR","CY 6023","2026-04-08",{"date":108,"type":37},"2026-04-13",{"date":110,"type":37},"2024-05-29",{"date":112,"type":22},"2030-01",{"name":43,"class":44},38,""]