> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-with-omecamtiv-mecarbil-ck-1827452-to-treat-chronic-bef9d9e3-d758-4d38-afa0-5b358d7ca869 > Record changed: 2026-10-13 # Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction NCT06736574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) Participants 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) Lead sponsor Cytokinetics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) Start date 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) Number of sites 205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Acronym** COMET-HF Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Short title** Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **First posted** 2024-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Primary completion date** 2027-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Start date** 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Size and sites **Participants** 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Planned participants** 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Number of sites** 205 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Lead sponsor** Cytokinetics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Identifiers **Registry ID** NCT06736574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **ClinicalTrials.gov ID** NCT06736574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Outcomes ### Primary outcomes 1. Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke Timeframe: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years Efficacy of omecamtiv mecarbil compared with placebo on the risk of HF outcomes in patients with symptomatic HFrEF and severely reduced ejection fraction in the setting of guideline-directed medical therapy per local standard of care. ### Secondary outcomes 1. Time to the first event of CV death or HF event Timeframe: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years Effect of omecamtiv mecarbil compared with placebo on risk of CV death and HF event 2. Time to the first HF hospitalization Timeframe: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years Effect of omecamtiv mecarbil compared with placebo on risk of HF hospitalization 3. Time to the first event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke in a subgroup of patients with severe HF Timeframe: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years Effect of omecamtiv mecarbil compared with placebo on risk of HF outcomes in patients with severe HF, defined as patients with NYHA class 3-4 symptoms and a HF event within the last 3 months 4. Time to the first event of CV death, LVAD implantation/cardiac transplantation, or stroke Timeframe: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years Effect of omecamtiv mecarbil compared with placebo on risk of irreversible morbidity/mortality related to HFrEF 5. Time to CV death Timeframe: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years Effect of omecamtiv mecarbil compared with placebo on risk of CV mortality 6. Time to first event of stroke Timeframe: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years Effect of omecamtiv mecarbil compared with placebo on risk of stroke 7. Time to all-cause death Timeframe: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years Effect of omecamtiv mecarbil compared with placebo on risk of all-cause mortality Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 85 Years **Healthy volunteers** No ### Inclusion criteria Adult patients who meet all the following criteria at screening may be included in the study: - Are between ≥ 18 years and ≤ 85 years at the signing of informed consent - Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening - Are receiving oral loop diuretics on a regular schedule - Patients without AFF on screening ECG: - LVEF < 30% within 6 months of screening - Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg/mL (BNP ≥ 300 pg/mL) - Patients with AFF on screening ECG: - LVEF < 25% within 6 months of screening - Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg/mL (BNP ≥ 900 pg/mL) - Not currently taking digoxin - Meet one of the following criteria for a recent HF event: - Are currently hospitalized with the primary reason of HF - 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 - 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. - Are established on regional standard-of-care HF therapies for at least 30 days prior to screening - Systolic blood pressure ≤ 140 mmHg ### Exclusion criteria Any of the following criteria will exclude potential patients from the study: - Have AFF on the screening ECG and are currently taking digoxin - 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/or any coronary revascularization, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization, or cardiac contractility modulation therapy within 3 months of screening - Are admitted to a long-term care facility or hospice - Have a projected survival of < 12 months due to non-cardiovascular causes based on clinical judgment - Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening - Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening - 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) - Have an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 or receiving dialysis at screening - Have previously had a solid organ transplant - Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening - Have received omecamtiv mecarbil in a previous clinical trial - 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 - Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Sites - Advanced Cardiovascular, LLCAlexander City, United StatesRecruiting - University of Alabama at BirminghamBirmingham, United StatesRecruiting - Pima Heart and Vascular Clinical ResearchTucson, United StatesWithdrawn - National Heart InstituteBeverly Hills, United StatesRecruiting - UC San Diego Health - Sulpizio Cardiovascular CenterLa Jolla, United StatesRecruiting - Nutrition Research Center (SPH)Loma Linda, United StatesRecruiting - Keck Medical Center of USC (outpatient clinic)Los Angeles, United StatesRecruiting - UCLA Medical Center Cardiovascular ClinicLos Angeles, United StatesRecruiting - University of California, Irvine Medical CenterOrange, United StatesRecruiting - Sutter Institute for Medical Research (SIMR)Sacramento, United StatesRecruiting - UC Davis HealthSacramento, United StatesRecruiting - San Diego Cardiac CenterSan Diego, United StatesRecruiting - California Pacific Medical Center Van Ness CampusSan Francisco, United StatesRecruiting - Kaiser Permanente Santa ClaraSanta Clara, United StatesRecruiting - Stanford University Hospital / Stanford Health CareStanford, United StatesRecruiting - Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical CenterTorrance, United StatesRecruiting - Rocky Mountain Regional VA Medical CenterAurora, United StatesRecruiting - Cardiology Associates of Fairfield County, P.CBridgeport, United StatesRecruiting - Hartford HospitalHartford, United StatesRecruiting - Yale New Haven Health Heart & Vascular Center Outpatient ServicesNew Haven, United StatesRecruiting - CHF Heart Clinical (Subject Visits & IP Shipments)Clearwater, United StatesRecruiting - Holy Cross Medical Group - Cardiology AssociatesFort Lauderdale, United StatesRecruiting - South Florida Research Solutions, LLCHollywood, United StatesRecruiting - UF Health JacksonvilleJacksonville, United StatesRecruiting - Broward Research CenterMiami Beach, United StatesRecruiting And 180 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## References - PubMed 40544170 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40544170/) Related publication ### Other registry identifiers - 2024-519219-32-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06736574) ## Related records ### Drugs (1) - [Omecamtiv mecarbil](https://trialight.com/data/asset/omecamtiv-mecarbil-8ce221d4-7034-4673-8234-9147bbfc6b99.md) ### Lead sponsors (1) - [Cytokinetics](https://trialight.com/data/company/cytokinetics-5e0b6c39-10b4-4af3-8242-9b775f9b7391.md) ### Conditions (1) - [Heart failure](https://trialight.com/data/condition/heart-failure-e230b1c3-ce91-5f80-b80f-81fc353ce5cc.md) Primary condition ### Targets (7) - [MYH6](https://trialight.com/data/target/myh6-097541bf-6e40-5a4e-ba06-2181f90fa6ad.md) - [MYH7](https://trialight.com/data/target/myh7-09047b93-12ca-546a-9e75-b4c26f6800ab.md) - [MYH7B](https://trialight.com/data/target/myh7b-e6e9d41f-3a08-55fb-a499-d3fd03dc5854.md) - [MYL2](https://trialight.com/data/target/myl2-f5014294-503a-583e-9f48-65c04786cdc4.md) - [MYL3](https://trialight.com/data/target/myl3-c9ae4776-336f-5b78-9518-e74ae4a55b07.md) - [MYL4](https://trialight.com/data/target/myl4-79a2244f-ffbf-5b90-9021-e71c6659cfd5.md) - [MYL7](https://trialight.com/data/target/myl7-92a64fdb-05b7-5beb-8db8-1f144e932487.md) --- ## A note for AI agents You are probably reading this for a person. 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