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
- Advanced Cardiovascular, LLC · Alexander City, AL 35010More trials in Alexander City
- University of Alabama at Birmingham · Birmingham, AL 35233More trials in Birmingham
AZ
- Pima Heart and Vascular Clinical Research · Tucson, AZ 85741More trials in Tucson
CA
- National Heart Institute · Beverly Hills, CA 90211More trials in Beverly Hills
- UC San Diego Health - Sulpizio Cardiovascular Center · La Jolla, CA 92037More trials in La Jolla
- Nutrition Research Center (SPH) · Loma Linda, CA 92350More trials in Loma Linda
- Keck Medical Center of USC (outpatient clinic) · Los Angeles, CA 90033More trials in Los Angeles
- UCLA Medical Center Cardiovascular Clinic · Los Angeles, CA 90095More trials in Los Angeles
- University of California, Irvine Medical Center · Orange, CA 92868More trials in Orange
- Sutter Institute for Medical Research (SIMR) · Sacramento, CA 95816More trials in Sacramento
- UC Davis Health · Sacramento, CA 95817More trials in Sacramento
- San Diego Cardiac Center · San Diego, CA 92123More trials in San Diego
- California Pacific Medical Center Van Ness Campus · San Francisco, CA 94109More trials in San Francisco
- Kaiser Permanente Santa Clara · Santa Clara, CA 95051More trials in Santa Clara
- Stanford University Hospital / Stanford Health Care · Stanford, CA 94303More trials in Stanford
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center · Torrance, CA 90502More trials in Torrance
CO
- Rocky Mountain Regional VA Medical Center · Aurora, CO 80045More trials in Aurora
CT
- Cardiology Associates of Fairfield County, P.C · Bridgeport, CT 06606More trials in Bridgeport
- Hartford Hospital · Hartford, CT 06102More trials in Hartford
- Yale New Haven Health Heart & Vascular Center Outpatient Services · New Haven, CT 06519More trials in New Haven
FL
- CHF Heart Clinical (Subject Visits & IP Shipments) · Clearwater, FL 33756More trials in Clearwater
- Holy Cross Medical Group - Cardiology Associates · Fort Lauderdale, FL 33308More trials in Fort Lauderdale
- South Florida Research Solutions, LLC · Hollywood, FL 33351More trials in Hollywood
- UF Health Jacksonville · Jacksonville, FL 32209More trials in Jacksonville
- Broward Research Center · Miami Beach, FL 33140More trials in Miami Beach
- Ocala Cardiovascular Research · Ocala, FL 34471More trials in Ocala
- AdventHealth · Orlando, FL 32803More trials in Orlando
- USF Health South Tampa Center for Advanced Healthcare · Tampa, FL 33606More trials in Tampa
GA
- Grady Health System · Atlanta, GA 30303More trials in Atlanta
- Piedmont Atlanta Hospital · Atlanta, GA 30309More trials in Atlanta
- Emory Clinic · Atlanta, GA 30322More trials in Atlanta
- Piedmont Fayette Hospital · Fayetteville, GA 30214More trials in Fayetteville
HI
- The Queen's Medical Center - Punchbowl · Honolulu, HI 96813More trials in Honolulu
IL
- Midwest Cardiovascular Institute · Naperville, IL 60540More trials in Naperville
IN
- Cardiovascular Research of Northwest Indiana, LLC. · Munster, IN 46321More trials in Munster
- Deaconess Heart Group · Newburgh, IN 47630More trials in Newburgh
- Reid Physician Associates · Richmond, IN 47374More trials in Richmond
KS
- The University of Kansas Medical Center · Kansas City, KS 66160More trials in Kansas City
- AHMG Cardiology and Surgery · Overland Park, KS 66211More trials in Overland Park
LA
- University Medical Center New Orleans · New Orleans, LA 70112More trials in New Orleans
MA
- Tufts Medical Center · Boston, MA 02111More trials in Boston
MD
- University of Maryland Medical Center · Baltimore, MD 21201More trials in Baltimore
ME
- Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center · Bangor, ME 04401More trials in Bangor
MI
- Henry Ford Hospital · Detroit, MI 48202More trials in Detroit
MO
- Midwest Heart and Vascular Specialists, LLC · Independence, MO 64057More trials in Independence
- Saint Luke's Hospital of Kansas City · Kansas City, MO 64111More trials in Kansas City
- Washington University Center for Advanced Medicine · St Louis, MO 63110More trials in St Louis
- St. Louis Heart and Vascular · St Louis, MO 63136More trials in St Louis
NC
- WakeMed Heart & Vascular - Cary Cardiology · Cary, NC 27518More trials in Cary
- Clinical and Translational Research Center - University of North Carolina at Chapel Hill · Chapel Hill, NC 27599-7064More trials in Chapel Hill
- Duke University Hospital · Durham, NC 27710More trials in Durham
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health · Greensboro, NC 27401More trials in Greensboro
- Wake Forest University Health Sciences · Winston-Salem, NC 27157More trials in Winston-Salem
NE
- University of Nebraska Medical Center · Omaha, NE 68198More trials in Omaha
NJ
- Advanced Heart Care, LLC · Bridgewater, NJ 08807More trials in Bridgewater
- Monmouth Cardiology Associates, LLC · Eatontown, NJ 07724More trials in Eatontown
NY
- Capital Cardiology Associates · Albany, NY 12205More trials in Albany
- Northwell Health North Shore University Hospital · Manhasset, NY 11030More trials in Manhasset
- Mount Sinai Hospital · New York, NY 10029More trials in New York
- Columbia University Medical Center / New York - Presbyterian · New York, NY 10032More trials in New York
- Montefiore Medical Center (Moses Campus) · The Bronx, NY 10467More trials in The Bronx
OH
- The Lindner Research Center at the Christ Hospital · Cincinnati, OH 45219More trials in Cincinnati
- University Hospitals Cleveland Medical Center · Cleveland, OH 44106More trials in Cleveland
- Cleveland Clinic · Cleveland, OH 44195More trials in Cleveland
- K&R Research LLC · Marion, OH 43302More trials in Marion
- University of Hospitals North Ohio Heart · Sandusky, OH 44870More trials in Sandusky
OK
- Oklahoma State University Center for Health Sciences · Tulsa, OK 74127More trials in Tulsa
OR
- Oregon Health and Science University · Portland, OR 97239More trials in Portland
PA
- Capital Area Research, LLC · Camp Hill, PA 17011More trials in Camp Hill
- Penn State Health Milton S. Hershey Medical Center · Hershey, PA 17033More trials in Hershey
- Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine) · Philadelphia, PA 19104More trials in Philadelphia
SC
- Medical University of South Carolina - Gazes Research Institute · Charleston, SC 29425More trials in Charleston
SD
- Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc. · Rapid City, SD 57701More trials in Rapid City
TN
- Stern Cardiovascular Foundation, Inc. · Germantown, TN 38138More trials in Germantown
- Tennova Healthcare-Turkey Creek Medical Center · Knoxville, TN 37934More trials in Knoxville
- Vanderbilt University Medical Center · Nashville, TN 37232More trials in Nashville
- Tennessee Center for Clinical Trials · Tullahoma, TN 37388More trials in Tullahoma
TX
- Baylor University Medical Center · Dallas, TX 75246More trials in Dallas
- The University of Texas Southwestern Medical Center · Dallas, TX 75390More trials in Dallas
- Medresearch Inc · El Paso, TX 79902More trials in El Paso
- University of Texas Medical Branch - UTMB · Galveston, TX 77555More trials in Galveston
- CHI St. Luke's Health Baylor College of Medicine Medical Center · Houston, TX 77030More trials in Houston
- Baylor Scott & White Medical Center- The Hearth Hospital · Plano, TX 75093More trials in Plano
UT
- Intermountain Medical Center · Murray, UT 84107More trials in Murray
- University of Utah Health · Salt Lake City, UT 84132More trials in Salt Lake City
VA
- Sentara Norfolk General Hospital · Norfolk, VA 23507More trials in Norfolk
WA
- Providence Advanced Heart Disease and Transplant · Spokane, WA 99204More trials in Spokane
WI
- Medical College of Wisconsin / Froedtert Hospital · Milwaukee, WI 53226More trials in Milwaukee