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

Inclusion Criteria:

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

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

• Current hospitalization or recently discharged with the primary diagnosis of heartfailure

• 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-typenatriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients insinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients withatrial fibrillation (AF), measured during the current hospitalization or in the 72hours prior to hospital admission

• Fulfillment of protocol defined stabilization criteria (if randomized duringhospitalization)

• Treatment during the index hospitalization with at least 1 intravenous dose of aloop 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 >5.0mmol/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 primarycause 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, orpericardial 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 thisstudy