[{"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:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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","2026-08-14",{"date":36,"type":37},"2026-08-18","ACTUAL",{"date":39,"type":37},"2024-12-19",{"date":41,"type":22},"2027-12",{"name":43,"class":44},"Cytokinetics","INDUSTRY",201,{"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,""]