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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

85 Years

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
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
Are currently hospitalized with the primary reason of HF, or had an HF event within 6 months prior to screening
Are established on regional standard-of-care HF therapies for at least 30 days prior to screening
Systolic blood pressure ≤ 130 mmHg and diastolic blood pressure ≤ 90 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 acute coronary syndrome, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization 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
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 previously received omecamtiv mecarbil
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