A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) (CONFIRMATION)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Hospitalized
Eligibility Criteria
Inclusion Criteria: Provide electronic or written informed consent, either personally or through a legally authorized representative Age ≥18 years or legal age of majority 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) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 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 Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² and/or serum/plasma potassium >5.0 mmol/L Type 1 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 Any other condition or therapy which would make the patient unsuitable for this study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Finerenone plus empagliflozin
Usual care
Usual care management