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

Colorado Prevention Center Clinical Research

Status and phase

Enrolling

Phase 3

Conditions

Heart Failure

Treatments

Drug: Empagliflozin

Drug: Finerenone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06024746

202303CPC

Details and patient eligibility

About

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.

Full 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).

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission
Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization)
Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).
Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

Exclusion criteria

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
Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
Prior or planned heart transplant
Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure
Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
Probable alternative cause of participant's heart failure symptoms
Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
Known hypersensitivity to the IP (active substance or excipients)
Any other condition or therapy which would make the patient unsuitable for this study