RecruitingPhase 3

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Estimated duration of participation: Up to 3 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether omecamtiv mecarbil can lower the risk of hospital stays, heart transplants, or death from heart failure. It is for adults with long-term heart failure whose hearts pump out much less blood than normal.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 85 years old when you sign the consent form.
  • You have needed treatment for heart failure with weak pumping for at least 3 months and regularly take loop diuretics (water pills) by mouth.
  • If your heart rhythm test shows no atrial fibrillation or flutter (AFF, abnormal heart rhythms): your ejection fraction must be below 30%, measured within 6 months. This is the share of blood your heart pumps out with each beat. Your heart strain blood test must show NT-proBNP of at least 1,000 pg/mL or BNP of at least 300 pg/mL.
  • If your heart rhythm test shows AFF: your ejection fraction must be below 25%, measured within 6 months. Your NT-proBNP must be at least 3,000 pg/mL or BNP at least 900 pg/mL. You must not be taking digoxin.
  • You are now in the hospital mainly for heart failure, or had a heart failure event that meets the study rules in the past 12 months. Another way to qualify is a water-pill increase outside the hospital for worsening heart failure: at least a 50% dose increase or a new type of water pill added to a loop diuretic, lasting at least 1 week.
  • You have been on the usual heart failure treatments in your region for at least 30 days.
  • Your top blood pressure number is 140 mmHg or lower.

Who can't join

  • You have AFF on your heart rhythm test and take digoxin, or had a heart event or procedure within 3 months that may have changed how well your heart pumps.
  • You are in long-term care or hospice, or your doctor expects you to live less than 12 months because of an illness not related to your heart or blood vessels.
  • Within 3 days, you received medicines through a vein to strengthen your heartbeat or raise blood pressure; or within 7 days, you needed a machine to support blood flow or breathing.
  • Within 12 hours, you received water pills or medicines to widen blood vessels through a vein, or extra oxygen. Oxygen used only at night for sleep apnea or heart failure is allowed.
  • Your kidney filtering test, called eGFR, is below 20 mL/min/1.73 m², you receive dialysis, or you have had a solid organ transplant.
  • You are being treated in another study of an experimental drug or device, ended that treatment within 30 days, or received omecamtiv mecarbil in an earlier trial.
  • You are pregnant, plan to become pregnant during the study, or plan to breastfeed during study treatment or within 5 days after it ends.
  • You have a heart muscle disease caused by substances building up in the heart, such as amyloid protein, or severely narrowed heart valves.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (88)

AL

AZ

CA

CO

CT

FL

GA

HI

IL

IN

KS

LA

MA

MD

ME

  • Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center · Bangor, ME 04401More trials in Bangor

MI

MO

NC

NE

NJ

NY

OH

OK

OR

PA

SC

SD

  • Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc. · Rapid City, SD 57701More trials in Rapid City

TN

TX

UT

VA

WA

WI