Tests omecamtiv mecarbil in adults with severe heart failure with reduced ejection fraction
Tests omecamtiv mecarbil against placebo in adults with symptomatic heart failure with reduced pumping.
Plain-language title generated from the registry record
Registry title: Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
Key facts
- Where
- Albany, Alexander City, Atlanta, Aurora, Baltimore, Bangor, Beverly Hills, Birmingham, Boston, Bridgeport, Bridgewater, Camp Hill, Cary, Chapel Hill, Charleston, Cincinnati, Clearwater, Cleveland, Dallas, Detroit, Durham, Eatontown, El Paso, Fayetteville, Fort Lauderdale, Galveston, Germantown, Greensboro, Hartford, Hershey, Hollywood, Honolulu, Houston, Independence, Jacksonville, Kansas City, Knoxville, La Jolla, Loma Linda, Los Angeles, Manhasset, Marion, Miami Beach, Milwaukee, Munster, Murray, Naperville, Nashville, New Haven, New Orleans, New York, Newburgh, Norfolk, Ocala, Omaha, Orange, Orlando, Overland Park, Philadelphia, Plano, Portland, Poughkeepsie, Rapid City, Richmond, Sacramento, Salt Lake City, San Diego, San Francisco, Sandusky, Santa Clara, Spokane, St Louis, Stanford, Tampa, The Bronx, Torrance, Tucson, Tullahoma, Tulsa, and Winston-Salem, United StatesSee the 90 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06736574, who can take part
Where in United States
- Capital Cardiology AssociatesAlbany, United StatesTaking people
- Advanced Cardiovascular, LLCAlexander City, United StatesTaking people
- Emory ClinicAtlanta, United StatesTaking people
- Grady Health SystemAtlanta, United StatesTaking people
- Piedmont Atlanta HospitalAtlanta, United StatesTaking people
- Rocky Mountain Regional VA Medical CenterAurora, United StatesTaking people
- University of Maryland Medical CenterBaltimore, United StatesTaking people
- Eastern Main Medical Center dba Northern Light Eastern Maine Medical CenterBangor, United StatesTaking people
- National Heart InstituteBeverly Hills, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- Tufts Medical CenterBoston, United StatesTaking people
- Cardiology Associates of Fairfield County, P.CBridgeport, United StatesTaking people
- Advanced Heart Care LLCBridgewater, United StatesTaking people
- Capital Area Research, LLCCamp Hill, United StatesTaking people
- WakeMed Heart & Vascular - Cary CardiologyCary, United StatesTaking people
- Clinical and Translational Research Center - University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- Medical University of South Carolina Gazes Research InstituteCharleston, United StatesTaking people
- The Lindner Research Center at the Christ HospitalCincinnati, United StatesTaking people
- CHF Heart Clinical (Subject Visits & IP Shipments)Clearwater, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- University Hospitals Cleveland Medical Center*Cleveland, United StatesTaking people
- Baylor University Medical CenterDallas, United StatesTaking people
- The University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- Henry Ford HospitalDetroit, United StatesTaking people
- Duke University HospitalDurham, United StatesTaking people
- Monmouth Cardiology Associates, LLCEatontown, United StatesTaking people
- Medresearch IncEl Paso, United StatesNo longer taking part
- Piedmont Fayette HospitalFayetteville, United StatesTaking people
- Holy Cross Medical Group - Cardiology AssociatesFort Lauderdale, United StatesTaking people
- University of Texas Medical Branch - UTMBGalveston, United StatesTaking people
- Stern Cardiovascular Foundation, Inc.Germantown, United StatesTaking people
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone HealthGreensboro, United StatesTaking people
- Hartford HospitalHartford, United StatesTaking people
- Penn State Health Milton S. Hershey Medical CenterHershey, United StatesTaking people
- South Florida Research Solutions, LLCHollywood, United StatesTaking people
- The Queen's Medical Center - PunchbowlHonolulu, United StatesTaking people
- CHI St. Luke's Health Baylor College of Medicine Medical CenterHouston, United StatesTaking people
- Midwest Heart and Vascular Specialists, LLCIndependence, United StatesNo longer taking part
- UF Health JacksonvilleJacksonville, United StatesTaking people
- Saint Luke's Hospital of Kansas CityKansas City, United StatesTaking people
- The University of Kansas Medical CenterKansas City, United StatesTaking people
- Tennova Healthcare-Turkey Creek Medical CenterKnoxville, United StatesTaking people
- UC San Diego Health-Sulpizio Cardiovascular CenterLa Jolla, United StatesTaking people
- Nutrition Research Center (SPH)Loma Linda, United StatesTaking people
- Keck Medical Center of USC (outpatient clinic)Los Angeles, United StatesTaking people
- UCLA Medical Center Cardiovascular ClinicLos Angeles, United StatesTaking people
- Northwell Health North Shore University HospitalManhasset, United StatesTaking people
- K&R Research LLCMarion, United StatesNo longer taking part
- Broward Research CenterMiami Beach, United StatesTaking people
- Medical College of Wisconsin/ Froedtert HospitalMilwaukee, United StatesTaking people
- Cardiovascular Research of Northwest Indiana, LLCMunster, United StatesTaking people
- Intermountain Medical CenterMurray, United StatesTaking people
- Midwest Cardiovascular InstituteNaperville, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Yale New Haven Health Heart & Vascular Center Outpatient ServicesNew Haven, United StatesTaking people
- University Medical Center New OrleansNew Orleans, United StatesTaking people
- Columbia University Medical Center New York PresbyterianNew York, United StatesTaking people
- Mount Sinai HospitalNew York, United StatesTaking people
- Deaconess Heart GroupNewburgh, United StatesTaking people
- Sentara Norfolk General HospitalNorfolk, United StatesNo longer taking part
- Ocala Cardiovascular ResearchOcala, United StatesTaking people
- University of Nebraska Medical CenterOmaha, United StatesTaking people
- University of California Irvine Medical CenterOrange, United StatesTaking people
- AdventHealthOrlando, United StatesTaking people
- AHMG Cardiology and SurgeryOverland Park, United StatesTaking people
- Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)Philadelphia, United StatesTaking people
- Baylor Scott & White Medical Center- The Hearth HospitalPlano, United StatesTaking people
- Oregon Health and Science UniversityPortland, United StatesTaking people
- Hudson Valley Cardiovascular PracticePoughkeepsie, United StatesTaking people
- Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.Rapid City, United StatesTaking people
- Reid Physician AssociatesRichmond, United StatesTaking people
- Sutter Institute for Medical Research (SIMR)Sacramento, United StatesTaking people
- UC Davis HealthSacramento, United StatesTaking people
- University Of Utah HealthSalt Lake City, United StatesTaking people
- San Diego Cardiac CenterSan Diego, United StatesTaking people
- California Pacific Medical Center Van Ness CampusSan Francisco, United StatesTaking people
- University of Hospitals North Ohio HeartSandusky, United StatesNo longer taking part
- Kaiser Permanente Santa ClaraSanta Clara, United StatesTaking people
- Providence Advanced Heart Disease and TransplantSpokane, United StatesTaking people
- Washington University Center for Advanced MedicineSt Louis, United StatesTaking people
- St Louis Heart and VascularSt Louis, United StatesNo longer taking part
- Stanford University Hospital / Stanford Health CareStanford, United StatesTaking people
- Saint Josephs HospitalsTampa, United StatesTaking people
- USF Health South Tampa Center for Advanced HealthcareTampa, United StatesTaking people
- Montefiore Medical Center - Moses CampusThe Bronx, United StatesTaking people
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorrance, United StatesTaking people
- Pima Heart and Vascular Clinical ResearchTucson, United StatesNo longer taking part
- Tennessee Center for Clinical TrialsTullahoma, United StatesTaking people
- Oklahoma State University Center for Health SciencesTulsa, United StatesTaking people
- Wake Forest University Health SciencesWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cytokinetics
- Trial code
- NCT06736574EU 2024-519219-32-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Have AFF on the screening ECG and are currently taking digoxin; 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 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; 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; Have an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 or receiving dialysis at screening; Any of the following criteria will exclude potential patients from the study:; 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.