Conditions: Heart Failure
Keywords: Heart Decompensation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1066
Healthy volunteers: no

Brief summary:
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

Detailed description:

Arms:
arm 1: Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. arm 2: Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. arm 3: Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. arm 4: Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. arm 5: Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days. arm 6: Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days.

Interventions: intervention 1: Finerenone (BAY94-8862) intervention 2: Placebo intervention 3: Inspra (eplerenone)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: