Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
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Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure
Heart failure signs and symptoms at the time of hospital admission
Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)
Documented prior history of severe hyperkalemia in the setting of MRA use
Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or potassium >5.0 mmol/L at screening
Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
Parallel
Finerenone
DrugOral finerenone
Placebo
DrugMatching oral placebo
Composite of total HF events and cardiovascular (CV) death.
Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
Number of serious adverse events.
Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Number of adverse events leading to discontinuation of study drug.
Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.
Time to first occurrence of the composite of CV death or HF event.
Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.
Total HF events.
Total HF events with finerenone compared to placebo.
Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
Time to CV death.
Time to CV death with finerenone compared to placebo.
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Colorado Prevention Center
Lead sponsor
St. Luke's Hospital, Kansas City, Missouri
Collaborator
Bayer
Collaborator