Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction

NCT06736574 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CY 10332024-519219-32-00
• Study Type: interventional
• Target: 1,800
• Locations: 9 countries
• Sites: 185

Brief 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.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction

Keywords

CK-1827452; omecamtiv mecarbil

Outcome Measures

Primary Outcomes (1)

• Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke

  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.

  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

Secondary Outcomes (7)

• Time to the first event of CV death or HF event

  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

• Time to the first HF hospitalization

  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

• Time to the first event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke in a subgroup of patients with severe HF

  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

• Time to the first event of CV death, 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

• Time to CV death

  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

Study Arms (2)

Omecamtiv Mecarbil

EXPERIMENTAL

Participants randomized to omecamtiv mecarbil will be dosed based on their omecamtiv mecarbil plasma concentration at 25, 37.5 or 50 mg twice daily until at least 850 participants experience a HF event or CV death, whichever comes first.

Drug: Omecamtiv Mecarbil (OM)

Placebo

PLACEBO COMPARATOR

Participants randomized to placebo will receive placebo twice daily until at least 850 participants experience a HF event or CV death, whichever comes first.

Drug: Placebo

Interventions

Omecamtiv Mecarbil (OM) DRUG

Oral Tablet

Omecamtiv Mecarbil

Placebo DRUG

Oral Tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytokinetics: lead

Study Sites (185)

Advanced Cardiovascular, LLC

Alexander City, Alabama, 35010, United States

RECRUITING

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Pima Heart and Vascular Clinical Research

Tucson, Arizona, 85741, United States

WITHDRAWN

National Heart Institute

Beverly Hills, California, 90211, United States

RECRUITING

UC San Diego Health - Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

RECRUITING

Nutrition Research Center (SPH)

Loma Linda, California, 92350, United States

RECRUITING

Keck Medical Center of USC (outpatient clinic)

Los Angeles, California, 90033, United States

RECRUITING

UCLA Medical Center Cardiovascular Clinic

Los Angeles, California, 90095, United States

RECRUITING

University of California, Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

Sutter Institute for Medical Research (SIMR)

Sacramento, California, 95816, United States

RECRUITING

UC Davis Health

Sacramento, California, 95817, United States

RECRUITING

San Diego Cardiac Center

San Diego, California, 92123, United States

RECRUITING

California Pacific Medical Center Van Ness Campus

San Francisco, California, 94109, United States

RECRUITING

Kaiser Permanente Santa Clara

Santa Clara, California, 95051, United States

RECRUITING

Stanford University Hospital / Stanford Health Care

Stanford, California, 94303, United States

RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

RECRUITING

Cardiology Associates of Fairfield County, P.C

Bridgeport, Connecticut, 06606, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

Yale New Haven Health Heart & Vascular Center Outpatient Services

New Haven, Connecticut, 06519, United States

RECRUITING

CHF Heart Clinical (Subject Visits & IP Shipments)

Clearwater, Florida, 33756, United States

RECRUITING

Holy Cross Medical Group - Cardiology Associates

Fort Lauderdale, Florida, 33308, United States

RECRUITING

South Florida Research Solutions, LLC

Hollywood, Florida, 33351, United States

RECRUITING

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

Broward Research Center

Miami Beach, Florida, 33140, United States

RECRUITING

Ocala Cardiovascular Research

Ocala, Florida, 34471, United States

RECRUITING

AdventHealth

Orlando, Florida, 32803, United States

RECRUITING

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, 33606, United States

RECRUITING

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

RECRUITING

Emory Clinic

Atlanta, Georgia, 30322, United States

RECRUITING

Piedmont Fayette Hospital

Fayetteville, Georgia, 30214, United States

RECRUITING

The Queen's Medical Center - Punchbowl

Honolulu, Hawaii, 96813, United States

RECRUITING

Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States

RECRUITING

Cardiovascular Research of Northwest Indiana, LLC.

Munster, Indiana, 46321, United States

RECRUITING

Deaconess Heart Group

Newburgh, Indiana, 47630, United States

RECRUITING

Reid Physician Associates

Richmond, Indiana, 47374, United States

RECRUITING

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

AHMG Cardiology and Surgery

Overland Park, Kansas, 66211, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center

Bangor, Maine, 04401, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Midwest Heart and Vascular Specialists, LLC

Independence, Missouri, 64057, United States

RECRUITING

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

Washington University Center for Advanced Medicine

St Louis, Missouri, 63110, United States

RECRUITING

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

WITHDRAWN

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Advanced Heart Care, LLC

Bridgewater, New Jersey, 08807, United States

RECRUITING

Monmouth Cardiology Associates, LLC

Eatontown, New Jersey, 07724, United States

RECRUITING

Capital Cardiology Associates

Albany, New York, 12205, United States

RECRUITING

Northwell Health North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Columbia University Medical Center / New York - Presbyterian

New York, New York, 10032, United States

RECRUITING

Montefiore Medical Center (Moses Campus)

The Bronx, New York, 10467, United States

RECRUITING

WakeMed Heart & Vascular - Cary Cardiology

Cary, North Carolina, 27518, United States

RECRUITING

Clinical and Translational Research Center - University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7064, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health

Greensboro, North Carolina, 27401, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

The Lindner Research Center at the Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

K&R Research LLC

Marion, Ohio, 43302, United States

WITHDRAWN

University of Hospitals North Ohio Heart

Sandusky, Ohio, 44870, United States

RECRUITING

Oklahoma State University Center for Health Sciences

Tulsa, Oklahoma, 74127, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011, United States

RECRUITING

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Medical University of South Carolina - Gazes Research Institute

Charleston, South Carolina, 29425, United States

RECRUITING

Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.

Rapid City, South Dakota, 57701, United States

RECRUITING

Stern Cardiovascular Foundation, Inc.

Germantown, Tennessee, 38138, United States

RECRUITING

Tennova Healthcare-Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, 37388, United States

RECRUITING

Baylor University Medical Center

Dallas, Texas, 75246, United States

RECRUITING

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Medresearch Inc

El Paso, Texas, 79902, United States

RECRUITING

University of Texas Medical Branch - UTMB

Galveston, Texas, 77555, United States

RECRUITING

CHI St. Luke's Health Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott & White Medical Center- The Hearth Hospital

Plano, Texas, 75093, United States

RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

University of Utah Health

Salt Lake City, Utah, 84132, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Providence Advanced Heart Disease and Transplant

Spokane, Washington, 99204, United States

RECRUITING

Medical College of Wisconsin / Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Mazankowski Alberta Heart Institute / University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

RECRUITING

Kelowna General Hospital

Kelowna, British Columbia, V1Y1T2, Canada

RECRUITING

SMH - Cardiology Clinical Trials Inc.

Surrey, British Columbia, V3V0C6, Canada

RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

Victoria Heart Institute Foundation

Victoria, British Columbia, V8R1B2, Canada

RECRUITING

St. Boniface Hospital

Winnipeg, Manitoba, R2H2A6, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

RECRUITING

Oakville Trafalgar Memorial Hospital - Halton Healthcare

Oakville, Ontario, L6M0L8, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N1J7, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

RECRUITING

UHN-Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

RECRUITING

Diex Recherche Sherbrooke

Sherbrooke, Quebec, J1L0H8, Canada

RECRUITING

CISSSL - Hopital Pierre-Le Gardeur

Terrebonne, Quebec, J6V 2H2, Canada

RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, Haute-Garonne, 31059, France

RECRUITING

Polyclinique Vauban

Valenciennes, Hauts-de-France, 59300, France

RECRUITING

CHU de Rennes - Hôpital Pontchaillou

Rennes, Ille-et-Vilaine, 35033, France

RECRUITING

Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon

La Tronche, Isère, 38700, France

RECRUITING

CHU de Montpellier- Hôpital Arnaud de Villeneuve

Montpellier, Occitanie, 34295, France

RECRUITING

L'Hôpital Privé Du Confluent

Nantes, Pays de la Loire Region, 44277, France

RECRUITING

Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer (C.H.I.T.S)

Toulon, Var, 83100, France

RECRUITING

Hôpital Lariboisière - APHP

Paris, Île-de-France Region, 75010, France

RECRUITING

Hôpital Européen Georges Pompidou

Paris, Île-de-France Region, 75015, France

RECRUITING

APHP - Hôpital Bichât

Paris, Île-de-France Region, 75018, France

RECRUITING

Heidelberg University Hospital, Clinic for Cardiology, Angiology and Pneum

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

LMU Klinikum - Medizinische Klinik und Poliklinik I

München, Bavaria, 81377, Germany

RECRUITING

Universitätsklinik Würzburg Deutsches Zentrum für Herzinsuffizienz

Würzburg, Bavaria, 97078, Germany

RECRUITING

UKE, Klinik fur Kardiologie

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

RECRUITING

UKE, Klinik für Kardiologie

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

RECRUITING

Helios Klinikum Erfurt GmbH

Erfurt, Germany, 99089, Germany

RECRUITING

Universitaetsklinikum Jena

Jena, Germany, 07747, Germany

RECRUITING

Marienhaus Klinikum Mainz GmbH

Mainz, Germany, 55131, Germany

RECRUITING

Kerckhoff-Klinik GmbH

Bad Nauheim, Hesse, 61231, Germany

RECRUITING

Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Asklepios Klinik Langen-Seligenstadt GmbH

Langen, Hesse, 63225, Germany

RECRUITING

Universitaetsmedizin Goettingen

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Dr. med. Jens Taggeselle

Markkleeberg, Saxony, 04416, Germany

RECRUITING

General Hospital of Athens ''G. Gennimatas''

Athens, Attica, 11527, Greece

RECRUITING

General Hospital of Athens ''Hippokratio''

Athens, Attica, 11527, Greece

RECRUITING

General Hospital of Nea Ionia ''Konstantopouleio-Patision''

Athens, Attica, 14233, Greece

RECRUITING

University General Hospital ''ATTIKON'' - General Hospital of West Attica H

Chaïdári, Attica, 12462, Greece

RECRUITING

General Hospital ''Asklepieio Voulas''

Voula, Attica, 16673, Greece

RECRUITING

General Hospital of Chalkida

Chalcis, Euboea, 34100, Greece

RECRUITING

University General Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

RECRUITING

University General Hospital of Larissa

Larissa, Larissa, 41110, Greece

RECRUITING

Papageorgiou General Hospital of Thessaloniki

Efkarpia, Thessaloniki, 56403, Greece

RECRUITING

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Thessaloniki, 54636, Greece

RECRUITING

ASST Spedali Civili di Brescia

Brescia, BS, 25123, Italy

RECRUITING

Ospedale Infermi

Rimini, Emilia-Romagna, 47923, Italy

RECRUITING

Ospedale di Arzignano

Arzignano, Lombardy, 36071, Italy

RECRUITING

ASST Papa Giovanni XXIII

Bergamo, Lombardy, 24127, Italy

RECRUITING

Centro Cardiologico Monzino

Milan, Lombardy, 20138, Italy

RECRUITING

IRCCS Multimedica

Sesto San Giovanni, Lombardy, 20099, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

A.O. Perugia - Ospedale S.Maria della Misericordia

Perugia, Province of Perugia, 06129, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna

Cona, 44124, Italy

RECRUITING

IRCCS San Raffaele

Roma, 00163, Italy

RECRUITING

Balsammedica Sp. z o.o.

Warsaw, Masovian Voivodeship, 01249, Poland

RECRUITING

Centralny Szpital Kliniczny UCK WUM

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15276, Poland

RECRUITING

Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II

Krakow, 31202, Poland

RECRUITING

SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi

Lodz, 90549, Poland

RECRUITING

SPZOZ Centralny Szpital Kliniczny UM w Lodzi

Lodz, 92213, Poland

RECRUITING

Szpital Sw. Anny w Miechowie

Miechów, 32200, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Opolu

Opole, 45401, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 61848, Poland

RECRUITING

Poradnia AKA-MED Centrum Sp. z o.o.

Ruda Śląska, 41710, Poland

RECRUITING

Tomasz Blicharski Lubelskie Centrum Diagnostyczne

Świdnik, 21040, Poland

RECRUITING

Wojewodzki Szpital Zespolony im. L. Rydygiera

Torun, 87100, Poland

RECRUITING

Hospital Universitario A Coruña

A Coruña, A Coruña, 15006, Spain

RECRUITING

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital San Juan de la Cruz

Úbeda, Jaen, 23400, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

RECRUITING

Hospital Universitari Joan XXIII de Tarragona

Tarragona, Tarragona, 43005, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Valencia, 46026, Spain

RECRUITING

Harefield Hospital

Harefield, Greater London, UB96JH, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, Hampshire, SO166YD, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, Scotland, G514TF, United Kingdom

RECRUITING

Basingstoke and North Hampshire Hospital

Basingstoke, RG249NA, United Kingdom

RECRUITING

Castle Hill Hospital

Cottingham, HU165JQ, United Kingdom

RECRUITING

Russells Hall Hospital

Dudley, DY12HQ, United Kingdom

RECRUITING

Ulster Hospital

Dundonald, BT161RH, United Kingdom

RECRUITING

Glasgow Royal Infirmary

Glasgow, G40SF, United Kingdom

RECRUITING

Great Western Hospitals

Swindon, SN36BB, United Kingdom

RECRUITING

Related Publications (1)

• Aksentijevic D, Sedej S, Fauconnier J, Paillard M, Abdellatif M, Streckfuss-Bomeke K, Ventura-Clapier R, van der Velden J, de Boer RA, Bertero E, Dudek J, Sequeira V, Maack C. Mechano-energetic uncoupling in heart failure. Nat Rev Cardiol. 2025 Oct;22(10):773-797. doi: 10.1038/s41569-025-01167-6. Epub 2025 Jun 22.

  PMID: 40544170 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

omecamtiv mecarbil

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Cytokinetics MD

  Cytokinetics

  STUDY DIRECTOR

Central Study Contacts

Cytokinetics MD

CONTACT

(650) 624-2929; medicalaffairs@cytokinetics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 16, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (10); CA (15); US (88); DE (14); IT (10); FR (10); GB (9); PL (12); ES (17)