NCT06024746

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

Combined Efficacy and Safety of an Early, Intensive, Management Strategy with Finerenone and SGLT2 Inhibitor in Patients Hospitalized with Heart Failure (CONFIRMATION-HF)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Colorado Prevention Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is an international, randomized, controlled, open-label, trial of an early, intensive management strategy using the combination of finerenone plus sodium-glucose co-transporter 2 inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Finerenone	Oral finerenone.
DRUG	Empagliflozin	Oral empagliflozin.

Timeline

• Start date: 2024-07-09
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2023-09-06
• Last updated: 2025-03-11

Locations

15 sites across 3 countries: United States, Brazil, Canada

Regulatory

• FDA-regulated drug study