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Clinical Trials in Turkey / NCT06736574
Recruiting Phase 3

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

NCT06736574 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 3
Started
2024-12-19
Last updated
2026-08-28

Condition(s) studied

Heart FailureHeart Failure With Reduced Ejection Fraction

Investigational drug(s) / intervention(s)

Omecamtiv Mecarbil (OM)Placebo

Omecamtiv Mecarbil (OM): Oral Tablet

Placebo: Oral Tablet

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (205)

FacilityCityRegionStatus
Advanced Cardiovascular, LLC Alexander City Alabama Recruiting
University of Alabama at Birmingham Birmingham Alabama Recruiting
Pima Heart and Vascular Clinical Research Tucson Arizona Withdrawn
National Heart Institute Beverly Hills California Recruiting
UC San Diego Health - Sulpizio Cardiovascular Center La Jolla California Recruiting
Nutrition Research Center (SPH) Loma Linda California Recruiting
Keck Medical Center of USC (outpatient clinic) Los Angeles California Recruiting
UCLA Medical Center Cardiovascular Clinic Los Angeles California Recruiting
University of California, Irvine Medical Center Orange California Recruiting
Sutter Institute for Medical Research (SIMR) Sacramento California Recruiting
UC Davis Health Sacramento California Recruiting
San Diego Cardiac Center San Diego California Recruiting
California Pacific Medical Center Van Ness Campus San Francisco California Recruiting
Kaiser Permanente Santa Clara Santa Clara California Recruiting
Stanford University Hospital / Stanford Health Care Stanford California Recruiting
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center Torrance California Recruiting
Rocky Mountain Regional VA Medical Center Aurora Colorado Recruiting
Cardiology Associates of Fairfield County, P.C Bridgeport Connecticut Recruiting
Hartford Hospital Hartford Connecticut Recruiting
Yale New Haven Health Heart & Vascular Center Outpatient Services New Haven Connecticut Recruiting
CHF Heart Clinical (Subject Visits & IP Shipments) Clearwater Florida Recruiting
Holy Cross Medical Group - Cardiology Associates Fort Lauderdale Florida Recruiting
South Florida Research Solutions, LLC Hollywood Florida Recruiting
UF Health Jacksonville Jacksonville Florida Recruiting
Broward Research Center Miami Beach Florida Recruiting
Ocala Cardiovascular Research Ocala Florida Recruiting
AdventHealth Orlando Florida Recruiting
USF Health South Tampa Center for Advanced Healthcare Tampa Florida Recruiting
Grady Health System Atlanta Georgia Recruiting
Piedmont Atlanta Hospital Atlanta Georgia Recruiting
Emory Clinic Atlanta Georgia Recruiting
Piedmont Fayette Hospital Fayetteville Georgia Recruiting
The Queen's Medical Center - Punchbowl Honolulu Hawaii Recruiting
Midwest Cardiovascular Institute Naperville Illinois Recruiting
Cardiovascular Research of Northwest Indiana, LLC. Munster Indiana Recruiting
Deaconess Heart Group Newburgh Indiana Recruiting
Reid Physician Associates Richmond Indiana Recruiting
The University of Kansas Medical Center Kansas City Kansas Recruiting
AHMG Cardiology and Surgery Overland Park Kansas Recruiting
University Medical Center New Orleans New Orleans Louisiana Recruiting

+ 165 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06736574 on ClinicalTrials.gov ↗ ← All trials in Turkey