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Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
NCT06736574 · Cytokinetics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
This study is designed to evaluate the efficacy and safety of omecamtiv mecarbil in reducing the risk of the primary composite endpoint of cardiovascular (CV) death, first heart failure (HF) event, left ventricular assist device (LVAD) implantation, cardiac transplantation, and stroke in patients with symptomatic heart failure with severely reduced ejection fraction (HFrEF).
Eligible patients will be randomized 1:1 to investigational product (IP) - omecamtiv mecarbil or placebo. The study is event-driven and will conclude when at least 850 participants experience a HF event or CV death, whichever comes first. An interim analysis for futility and efficacy based on the primary composite endpoint is planned when approximately 570 (67%) of the planned 850 first HF events or CV deaths are observed.
Estimated duration of participation: Up to 3 years.
Eligibility criteria
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
Study design
Enrollment target: 1800 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-12-19
Estimated completion: 2027-12
Last updated: 2026-02-17
Interventions
Drug: Omecamtiv Mecarbil (OM)Drug: Placebo
Primary outcomes
- • Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke (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)
Sponsor
Cytokinetics · industry
Contacts & investigators
ContactCytokinetics MD · contact · medicalaffairs@cytokinetics.com · (650) 624-2929
InvestigatorCytokinetics MD · study_director, Cytokinetics
All locations (183)
Advanced Cardiovascular, LLCRecruiting
Alexander City, Alabama, United States
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Pima Heart and Vascular Clinical ResearchWithdrawn
Tucson, Arizona, United States
National Heart InstituteRecruiting
Beverly Hills, California, United States
UC San Diego Health - Sulpizio Cardiovascular CenterRecruiting
La Jolla, California, United States
Nutrition Research Center (SPH)Recruiting
Loma Linda, California, United States
Keck Medical Center of USC (outpatient clinic)Recruiting
Los Angeles, California, United States
UCLA Medical Center Cardiovascular ClinicRecruiting
Los Angeles, California, United States
University of California, Irvine Medical CenterRecruiting
Orange, California, United States
Sutter Institute for Medical Research (SIMR)Recruiting
Sacramento, California, United States
UC Davis HealthRecruiting
Sacramento, California, United States
San Diego Cardiac CenterRecruiting
San Diego, California, United States
California Pacific Medical Center Van Ness CampusRecruiting
San Francisco, California, United States
Kaiser Permanente Santa ClaraRecruiting
Santa Clara, California, United States
Stanford University Hospital / Stanford Health CareRecruiting
Stanford, California, United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical CenterRecruiting
Torrance, California, United States
Rocky Mountain Regional VA Medical CenterRecruiting
Aurora, Colorado, United States
Cardiology Associates of Fairfield County, P.CRecruiting
Bridgeport, Connecticut, United States
Hartford HospitalRecruiting
Hartford, Connecticut, United States
Yale New Haven Health Heart & Vascular Center Outpatient ServicesRecruiting
New Haven, Connecticut, United States
CHF Heart Clinical (Subject Visits & IP Shipments)Recruiting
Clearwater, Florida, United States
Holy Cross Medical Group - Cardiology AssociatesRecruiting
Fort Lauderdale, Florida, United States
South Florida Research Solutions, LLCRecruiting
Hollywood, Florida, United States
UF Health JacksonvilleRecruiting
Jacksonville, Florida, United States
Broward Research CenterRecruiting
Miami Beach, Florida, United States
Ocala Cardiovascular ResearchRecruiting
Ocala, Florida, United States
AdventHealthRecruiting
Orlando, Florida, United States
USF Health South Tampa Center for Advanced HealthcareRecruiting
Tampa, Florida, United States
Grady Health SystemRecruiting
Atlanta, Georgia, United States
Piedmont Atlanta HospitalRecruiting
Atlanta, Georgia, United States
Emory ClinicRecruiting
Atlanta, Georgia, United States
Piedmont Fayette HospitalRecruiting
Fayetteville, Georgia, United States
The Queen's Medical Center - PunchbowlRecruiting
Honolulu, Hawaii, United States
Midwest Cardiovascular InstituteRecruiting
Naperville, Illinois, United States
Cardiovascular Research of Northwest Indiana, LLC.Recruiting
Munster, Indiana, United States
Deaconess Heart GroupRecruiting
Newburgh, Indiana, United States
Reid Physician AssociatesRecruiting
Richmond, Indiana, United States
The University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
AHMG Cardiology and SurgeryRecruiting
Overland Park, Kansas, United States
University Medical Center New OrleansRecruiting
New Orleans, Louisiana, United States
Eastern Main Medical Center dba Northern Light Eastern Maine Medical CenterRecruiting
Bangor, Maine, United States
University of Maryland Medical CenterRecruiting
Baltimore, Maryland, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Midwest Heart and Vascular Specialists, LLCRecruiting
Independence, Missouri, United States
Saint Luke's Hospital of Kansas CityRecruiting
Kansas City, Missouri, United States
Washington University Center for Advanced MedicineRecruiting
St Louis, Missouri, United States
St. Louis Heart and VascularWithdrawn
St Louis, Missouri, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Advanced Heart Care, LLCRecruiting
Bridgewater, New Jersey, United States
Monmouth Cardiology Associates, LLCRecruiting
Eatontown, New Jersey, United States
Capital Cardiology AssociatesRecruiting
Albany, New York, United States
Northwell Health North Shore University HospitalRecruiting
Manhasset, New York, United States
Mount Sinai HospitalRecruiting
New York, New York, United States
Columbia University Medical Center / New York - PresbyterianRecruiting
New York, New York, United States
Montefiore Medical Center (Moses Campus)Recruiting
The Bronx, New York, United States
WakeMed Heart & Vascular - Cary CardiologyRecruiting
Cary, North Carolina, United States
Clinical and Translational Research Center - University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Duke University HospitalRecruiting
Durham, North Carolina, United States
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone HealthRecruiting
Greensboro, North Carolina, United States
Wake Forest University Health SciencesRecruiting
Winston-Salem, North Carolina, United States
The Lindner Research Center at the Christ HospitalRecruiting
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
K&R Research LLCWithdrawn
Marion, Ohio, United States
University of Hospitals North Ohio HeartRecruiting
Sandusky, Ohio, United States
Oklahoma State University Center for Health SciencesRecruiting
Tulsa, Oklahoma, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Capital Area Research, LLCRecruiting
Camp Hill, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)Recruiting
Philadelphia, Pennsylvania, United States
Medical University of South Carolina - Gazes Research InstituteRecruiting
Charleston, South Carolina, United States
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.Recruiting
Rapid City, South Dakota, United States
Stern Cardiovascular Foundation, Inc.Recruiting
Germantown, Tennessee, United States
Tennova Healthcare-Turkey Creek Medical CenterRecruiting
Knoxville, Tennessee, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Tennessee Center for Clinical TrialsRecruiting
Tullahoma, Tennessee, United States
Baylor University Medical CenterRecruiting
Dallas, Texas, United States
The University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Medresearch IncRecruiting
El Paso, Texas, United States
University of Texas Medical Branch - UTMBRecruiting
Galveston, Texas, United States
CHI St. Luke's Health Baylor College of Medicine Medical CenterRecruiting
Houston, Texas, United States
Baylor Scott & White Medical Center- The Hearth HospitalRecruiting
Plano, Texas, United States
Intermountain Medical CenterRecruiting
Murray, Utah, United States
University of Utah HealthRecruiting
Salt Lake City, Utah, United States
Sentara Norfolk General HospitalRecruiting
Norfolk, Virginia, United States
Providence Advanced Heart Disease and TransplantRecruiting
Spokane, Washington, United States
Medical College of Wisconsin / Froedtert HospitalRecruiting
Milwaukee, Wisconsin, United States
Mazankowski Alberta Heart Institute / University of Alberta HospitalRecruiting
Edmonton, Alberta, Canada
Kelowna General HospitalRecruiting
Kelowna, British Columbia, Canada
SMH - Cardiology Clinical Trials Inc.Recruiting
Surrey, British Columbia, Canada
St. Paul's HospitalRecruiting
Vancouver, British Columbia, Canada
Victoria Heart Institute FoundationRecruiting
Victoria, British Columbia, Canada
St. Boniface HospitalRecruiting
Winnipeg, Manitoba, Canada
Kingston Health Sciences CentreRecruiting
Kingston, Ontario, Canada
London Health Sciences CentreRecruiting
London, Ontario, Canada
Oakville Trafalgar Memorial Hospital - Halton HealthcareRecruiting
Oakville, Ontario, Canada
Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
St. Michael's HospitalRecruiting
Toronto, Ontario, Canada
UHN-Toronto General HospitalRecruiting
Toronto, Ontario, Canada
Montreal Heart InstituteRecruiting
Montreal, Quebec, Canada
Diex Recherche SherbrookeRecruiting
Sherbrooke, Quebec, Canada
CISSSL - Hopital Pierre-Le GardeurRecruiting
Terrebonne, Quebec, Canada
Centre Hospitalier Universitaire de ToulouseRecruiting
Toulouse, Haute-Garonne, France
Polyclinique VaubanRecruiting
Valenciennes, Hauts-de-France, France
CHU de Rennes - Hôpital PontchaillouRecruiting
Rennes, Ille-et-Vilaine, France
Centre Hospitalier Universitaire Grenoble Alpes - Site Nord MichallonRecruiting
La Tronche, Isère, France
CHU de Montpellier- Hôpital Arnaud de VilleneuveRecruiting
Montpellier, Occitanie, France
L'Hôpital Privé Du ConfluentRecruiting
Nantes, Pays de la Loire Region, France
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer (C.H.I.T.S)Recruiting
Toulon, Var, France
Hôpital Lariboisière - APHPRecruiting
Paris, Île-de-France Region, France
Hôpital Européen Georges PompidouRecruiting
Paris, Île-de-France Region, France
APHP - Hôpital BichâtRecruiting
Paris, Île-de-France Region, France
LMU Klinikum - Medizinische Klinik und Poliklinik IRecruiting
München, Bavaria, Germany
Universitätsklinik Würzburg Deutsches Zentrum für HerzinsuffizienzRecruiting
Würzburg, Bavaria, Germany
UKE, Klinik fur KardiologieRecruiting
Hamburg, Free and Hanseatic City of Hamburg, Germany
UKE, Klinik für KardiologieRecruiting
Hamburg, Free and Hanseatic City of Hamburg, Germany
Helios Klinikum Erfurt GmbHRecruiting
Erfurt, Germany, Germany
Universitaetsklinikum JenaRecruiting
Jena, Germany, Germany
Marienhaus Klinikum Mainz GmbHRecruiting
Mainz, Germany, Germany
Kerckhoff-Klinik GmbHRecruiting
Bad Nauheim, Hesse, Germany
Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, AngiologieRecruiting
Frankfurt am Main, Hesse, Germany
Asklepios Klinik Langen-Seligenstadt GmbHRecruiting
Langen, Hesse, Germany
Universitaetsmedizin GoettingenRecruiting
Göttingen, Lower Saxony, Germany
Universitätsklinikum BonnRecruiting
Bonn, North Rhine-Westphalia, Germany
Dr. med. Jens TaggeselleRecruiting
Markkleeberg, Saxony, Germany
General Hospital of Athens ''G. Gennimatas''Recruiting
Athens, Attica, Greece
General Hospital of Athens ''Hippokratio''Recruiting
Athens, Attica, Greece
General Hospital of Nea Ionia ''Konstantopouleio-Patision''Recruiting
Athens, Attica, Greece
University General Hospital ''ATTIKON'' - General Hospital of West Attica HRecruiting
Chaïdári, Attica, Greece
General Hospital ''Asklepieio Voulas''Recruiting
Voula, Attica, Greece
University General Hospital of AlexandroupolisRecruiting
Alexandroupoli, Evros, Greece
University General Hospital of LarissaRecruiting
Larissa, Larissa, Greece
Papageorgiou General Hospital of ThessalonikiRecruiting
Efkarpia, Thessaloniki, Greece
AHEPA University General Hospital of ThessalonikiRecruiting
Thessaloniki, Thessaloniki, Greece
ASST Spedali Civili di BresciaRecruiting
Brescia, BS, Italy
Ospedale InfermiRecruiting
Rimini, Emilia-Romagna, Italy
Ospedale di ArzignanoRecruiting
Arzignano, Lombardy, Italy
ASST Papa Giovanni XXIIIRecruiting
Bergamo, Lombardy, Italy
Centro Cardiologico MonzinoRecruiting
Milan, Lombardy, Italy
IRCCS MultimedicaRecruiting
Sesto San Giovanni, Lombardy, Italy
IRCCS Ospedale San RaffaeleRecruiting
Milan, MI, Italy
A.O. Perugia - Ospedale S.Maria della MisericordiaRecruiting
Perugia, Province of Perugia, Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' AnnaRecruiting
Cona, Italy
IRCCS San RaffaeleRecruiting
Roma, Italy
Balsammedica Sp. z o.o.Recruiting
Warsaw, Masovian Voivodeship, Poland
Centralny Szpital Kliniczny UCK WUMRecruiting
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w BialymstokuRecruiting
Bialystok, Poland
Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla IIRecruiting
Krakow, Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w LodziRecruiting
Lodz, Poland
SPZOZ Centralny Szpital Kliniczny UM w LodziRecruiting
Lodz, Poland
Szpital Sw. Anny w MiechowieRecruiting
Miechów, Poland
Uniwersytecki Szpital Kliniczny w OpoluRecruiting
Opole, Poland
Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
Poznan, Poland
Poradnia AKA-MED Centrum Sp. z o.o.Recruiting
Ruda Śląska, Poland
Tomasz Blicharski Lubelskie Centrum DiagnostyczneRecruiting
Świdnik, Poland
Wojewodzki Szpital Zespolony im. L. RydygieraRecruiting
Torun, Poland
Hospital Universitario A CoruñaRecruiting
A Coruña, A Coruña, Spain
Hospital Clinico Universitario de SantiagoRecruiting
Santiago de Compostela, A Coruña, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Barcelona, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Barcelona, Spain
Hospital Universitari de BellvitgeRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital San Juan de la CruzRecruiting
Úbeda, Jaen, Spain
Hospital Universitario Lucus AugustiRecruiting
Lugo, Lugo, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Madrid, Spain
Hospital Universitario Puerta de HierroRecruiting
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de La ArrixacaRecruiting
El Palmar, Murcia, Spain
CHUVI - H.U. Alvaro CunqueiroRecruiting
Vigo, Pontevedra, Spain
Hospital Universitario de SalamancaRecruiting
Salamanca, Salamanca, Spain
Hospital Universitario Virgen del RocíoRecruiting
Seville, Sevilla, Spain
Hospital Universitari Joan XXIII de TarragonaRecruiting
Tarragona, Tarragona, Spain
Hospital Clínico Universitario de ValenciaRecruiting
Valencia, Valencia, Spain
Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
Valencia, Valencia, Spain
Harefield HospitalRecruiting
Harefield, Greater London, United Kingdom
Southampton General HospitalRecruiting
Southampton, Hampshire, United Kingdom
Queen Elizabeth University HospitalRecruiting
Glasgow, Scotland, United Kingdom
Basingstoke and North Hampshire HospitalRecruiting
Basingstoke, United Kingdom
Castle Hill HospitalRecruiting
Cottingham, United Kingdom
Russells Hall HospitalRecruiting
Dudley, United Kingdom
Ulster HospitalRecruiting
Dundonald, United Kingdom
Glasgow Royal InfirmaryRecruiting
Glasgow, United Kingdom
Great Western HospitalsRecruiting
Swindon, United Kingdom