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
- A Coruña, Barcelona, L'hospitalet De Llobregat, Lleida, Lugo, Madrid, Majadahonda, Málaga, Murcia, Salamanca, Santiago de Compostela, Sevilla, Tarragona, Ubeda, Jaen, Valencia, and Vigo, SpainSee the 19 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-standing heart failure and a very weak heart pump (severely reduced ejection fraction), who recently had a heart failure event.
- Age
- 18 to 85 years
- Sex
- Women and men can join.
- Disease stage
- Chronic heart failure with reduced ejection fraction, treated for at least 3 months. LVEF below 30% (below 25% if atrial fibrillation or flutter on ECG). Recent hospitalization for heart failure, a heart failure event in the last 12 months, or a recent increase in water tablets.
- Earlier treatment
- Must take loop diuretics regularly and be on standard heart failure treatment for at least 30 days. Must not have taken omecamtiv mecarbil in an earlier trial.
- Biomarker or test result
- NT-proBNP 1000 pg/mL or higher (BNP 300 pg/mL or higher). If atrial fibrillation or flutter on ECG: NT-proBNP 3000 pg/mL or higher (BNP 900 pg/mL or higher). Systolic blood pressure 140 mmHg or lower.
Main reasons for not taking part
- Atrial fibrillation or flutter on ECG while taking digoxin
- Heart attack, heart surgery or similar heart procedure within 3 months of screening
- Kidney function eGFR below 20 mL/min/1.73m2, or on dialysis
- Previous solid organ transplant
- Pregnant, planning pregnancy, or planning to breastfeed
Read by machine on 9 November 2026.
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 Spain
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Bellvitge University HospitalL'hospitalet De Llobregat, SpainTaking people
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De LleidaLleida, SpainTaking people
- Hospital Universitario Lucus AugustiLugo, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario La PazMadrid, SpainTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpainTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Hospital Universitari Joan XXIII de TarragonaTarragona, SpainTaking people
- Hospital San Juan de la CruzUbeda, Jaen, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
- Hospital Alvaro CunqueiroVigo, SpainTaking 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.