RecruitingHeart FailureHeart Failure With Reduced Ejection Fraction

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

Eligible age

18–85 yrs

Accepts

All genders

Locations

33 states

Healthy volunteers

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About this study

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.

Sponsor: Cytokinetics

You may qualify if…

✓ 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:

You may not qualify if…

✕ 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)