A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)

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

About this trial

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Eligibility criteria

Qualifiers

Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations

Age ≥18 years or legal age of majority if >18 years in the participant's country of residence

Current hospitalization or recently discharged with the primary diagnosis of heart failure

Heart failure signs and symptoms at the time of hospital admission

Disqualifiers

Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis

Documented prior history of severe hyperkalemia in the setting of MRA use

Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i

Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² and/or potassium >5.0 mmol/L

Trial design

Treatments tested in this trial

  • Finerenone
  • Empagliflozin

Treatment groups

1,500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Colorado Prevention Center

Lead sponsor

Saint Luke's Mid America Heart Institute

Collaborator

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Collaborator