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

Eligibility 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)
• * 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