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

Study Overview
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Brief Summary
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Combination therapy with finerenone with empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Detailed Description
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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).

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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Finerenone
* Drug: Empagliflozin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Finerenone plus empagliflozin<br> | Drug: Finerenone<br>* Oral finerenone.<br>Drug: Empagliflozin<br>* Oral empagliflozin.<br>|
| No Intervention: Usual care<br>Usual care management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit | Hierarchical composite of the following assessed by the win-ratio: Time to death from any cause Number of HF events Time to first HF event Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) | 6 months | 
| Number of serious adverse events (AEs). | - Serious AEs (excluding efficacy endpoints). | 6 months | 
| Number of adverse events leading to discontinuation of study drug. | - AEs leading to discontinuation of finerenone or empagliflozin. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of deaths from any cause and total HF events. | - All-cause mortality and total HF events (first and recurrent). | 6 months | 
| Change from baseline in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6. |  | 6 months | 
| Number of HF events at Day 90. | - Total (first and recurrent) HF events. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Hospitalized