Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
Recruiting · NCT06736574 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Omecamtiv Mecarbil (OM)Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 33 US states.
- Advanced Cardiovascular, LLC - Alexander City, Alabama, United States
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Pima Heart and Vascular Clinical Research - Tucson, Arizona, United States
- National Heart Institute - Beverly Hills, California, United States
- UC San Diego Health - Sulpizio Cardiovascular Center - La Jolla, California, United States
- Nutrition Research Center (SPH) - Loma Linda, California, United States
- Keck Medical Center of USC (outpatient clinic) - Los Angeles, California, United States
- UCLA Medical Center Cardiovascular Clinic - Los Angeles, California, United States
- University of California, Irvine Medical Center - Orange, California, United States
- Sutter Institute for Medical Research (SIMR) - Sacramento, California, United States
- UC Davis Health - Sacramento, California, United States
- San Diego Cardiac Center - San Diego, California, United States
- California Pacific Medical Center Van Ness Campus - San Francisco, California, United States
- Kaiser Permanente Santa Clara - Santa Clara, California, United States
- Stanford University Hospital / Stanford Health Care - Stanford, California, United States
- Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center - Torrance, California, United States
- Rocky Mountain Regional VA Medical Center - Aurora, Colorado, United States
- Cardiology Associates of Fairfield County, P.C - Bridgeport, Connecticut, United States
- Hartford Hospital - Hartford, Connecticut, United States
- Yale New Haven Health Heart & Vascular Center Outpatient Services - New Haven, Connecticut, United States
- CHF Heart Clinical (Subject Visits & IP Shipments) - Clearwater, Florida, United States
- Holy Cross Medical Group - Cardiology Associates - Fort Lauderdale, Florida, United States
- South Florida Research Solutions, LLC - Hollywood, Florida, United States
- UF Health Jacksonville - Jacksonville, Florida, United States
- Broward Research Center - Miami Beach, Florida, United States
- Ocala Cardiovascular Research - Ocala, Florida, United States
- AdventHealth - Orlando, Florida, United States
- USF Health South Tampa Center for Advanced Healthcare - Tampa, Florida, United States
- Grady Health System - Atlanta, Georgia, United States
- Piedmont Atlanta Hospital - Atlanta, Georgia, United States
- Emory Clinic - Atlanta, Georgia, United States
- Piedmont Fayette Hospital - Fayetteville, Georgia, United States
- The Queen's Medical Center - Punchbowl - Honolulu, Hawaii, United States
- Midwest Cardiovascular Institute - Naperville, Illinois, United States
- Cardiovascular Research of Northwest Indiana, LLC. - Munster, Indiana, United States
- Deaconess Heart Group - Newburgh, Indiana, United States
- Reid Physician Associates - Richmond, Indiana, United States
- The University of Kansas Medical Center - Kansas City, Kansas, United States
- AHMG Cardiology and Surgery - Overland Park, Kansas, United States
- University Medical Center New Orleans - New Orleans, Louisiana, United States
- Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center - Bangor, Maine, United States
- University of Maryland Medical Center - Baltimore, Maryland, United States
- Tufts Medical Center - Boston, Massachusetts, United States
- Henry Ford Hospital - Detroit, Michigan, United States
- Midwest Heart and Vascular Specialists, LLC - Independence, Missouri, United States
- Saint Luke's Hospital of Kansas City - Kansas City, Missouri, United States
- Washington University Center for Advanced Medicine - St Louis, Missouri, United States
- St. Louis Heart and Vascular - St Louis, Missouri, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Advanced Heart Care, LLC - Bridgewater, New Jersey, United States
- Monmouth Cardiology Associates, LLC - Eatontown, New Jersey, United States
- Capital Cardiology Associates - Albany, New York, United States
- Northwell Health North Shore University Hospital - Manhasset, New York, United States
- Mount Sinai Hospital - New York, New York, United States
- Columbia University Medical Center / New York - Presbyterian - New York, New York, United States
- Montefiore Medical Center (Moses Campus) - The Bronx, New York, United States
- WakeMed Heart & Vascular - Cary Cardiology - Cary, North Carolina, United States
- Clinical and Translational Research Center - University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- Duke University Hospital - Durham, North Carolina, United States
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health - Greensboro, North Carolina, United States
Showing 60 of 205 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →