- Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06736574.
- What is being tested: Omecamtiv mecarbil (CK-1827452), an investigational cardiac myosin activator, is being evaluated to determine if it reduces adverse outcomes including hospitalisation, transplantation, and mortality in chronic heart failure patients with severely reduced ejection fraction.
- Patient eligibility overview: The trial targets patients with chronic heart failure characterised by severely reduced left ventricular ejection fraction, representing a high-risk population with significant morbidity and mortality burden.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.