Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Key Inclusion Criteria:
- Subject has provided informed consent
- Male or female, ≥ 18 to ≤ 85 years
- History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization
- Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
- New York Heart Association (NYHA) class II to IV at most recent screening assessment.
- Managed with HF standard of care (SoC) therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
- Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
- Elevated B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic peptide (NT-proBNP)
Other Inclusion Criteria May apply
Key Exclusion Criteria:
- Currently receiving treatment in another investigational device or drug study, or < 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
- Subject has known sensitivity to any of the products or components to be administered during testing
Other Exclusion Criteria May apply
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Omecamtiv Mecarbil
Placebo
Participants received oral omecamtiv mecarbil (OM) twice daily in addition to standard heart failure therapy. The starting dose of OM was 25 mg; At week 4, participants with week 2 OM predose plasma concentrations < 200 ng/mL had their dose increased to 50 mg BID; participants with week 2 predose plasma concentrations ≥ 200 and < 300 ng/mL had their dose increased to 37.5 mg BID and participants with week 2 predose plasma concentrations ≥ 300 ng/mL and < 1000 ng/mL maintained a 25 mg BID dosing regimen.
Participants received matching placebo tablets twice a day in addition to standard heart failure therapy.