A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction ≥ 40% (LVEF ≥ 40%)

About this Study

The purpose of this study is to look at how well the study drug, Finerenone, works in patients with heart failure, to learn if the study drug is safe for the patients and how it affects the body

Sponsor Protocol ID:20103
IRB Number:2020V0284
Actively Enrolling
Phase 3
January 14, 2022
Eligibility Criteria
40 years old
Both Male and Female

Inclusion Criteria
  • Must be 40 years and older at the time of signing informed consent
  • Diagnosis of heart failure with NYHA class II-IV
  • Treated with diuretics (fluid pill) within 30 prior to randomization
  • Left ventricular ejection fraction of greater than 40% within the last 12 months
  • Problems with heart based on scan within the last 12 months
  • Male or female

Exclusion Criteria
  • eGFR less than 25 mL/min1.73 
  • Potassium greater than 5.0 mmol/L
  • Acute inflammatory heart disease within 90 days prior to randomization
  • Myocardial infarction (MI) or heart problem that would lower ejection fraction within 90 days prior to randomization
  • Coronary artery bypass graft surgery in the 90 day prior to randomization
  • Percutaneous coronary intervention in the 30 days prior to randomization
  • Stroke or transient ischemic cerebral attack within 90 days prior to randomization
  • Systolic blood pressure greater than or equal to 160 mmHg if not on treatment greater than or equal to 3 blood pressure lowering medications
  • Life threatening or uncontrolled abnormal heart beat at screening and/or randomization
  • Left ventricular assist device by the time of screening or randomization
  • Pregnant or nursing women
  • Addison's disease
  • Participation in another interventional clinical study