A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorColorado Prevention Center

About this trial

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.

Eligibility criteria

Qualifiers

Provide written informed consent

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Finerenone
  • Placebo

Treatment groups

5,200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Colorado Prevention Center

Lead sponsor

St. Luke's Hospital, Kansas City, Missouri

Collaborator

Bayer

Collaborator