Combining finerenone and SGLT2i for hospitalized heart failure patients

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

This study tests whether combining two medications, finerenone and empagliflozin, can help hospitalized heart failure patients feel better compared to standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Colorado Prevention Center (Academic / other)
• Locations: 15 sites (Fairhope, Alabama and 14 other locations)
• Trial ID: NCT06024746 on ClinicalTrials.gov

What this trial studies

This international, randomized, controlled, open-label trial evaluates the efficacy and safety of a combination therapy using finerenone and empagliflozin compared to usual care in patients hospitalized with heart failure. The study focuses on an early, intensive management strategy to improve outcomes for these patients. Participants will be monitored for heart failure signs and symptoms, and their eligibility will be determined based on specific biomarkers and hospitalization criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are currently hospitalized or recently discharged with a primary diagnosis of heart failure.

Not a fit: Patients who do not have heart failure or are not currently hospitalized may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery and outcomes for patients with heart failure.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in heart failure management, indicating potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Fairhope, Alabama and 14 other locations

• CON-10004 Fairhope, AL Investigational Site — Fairhope, Alabama, United States (Recruiting)
• CON-10075 El Centro, CA Investigational Site — El Centro, California, United States (Recruiting)
• CON-10024 Sacramento, CA Investigational Site — Sacramento, California, United States (Recruiting)
• CON-10022 Atlanta, GA Investigational Site — Atlanta, Georgia, United States (Recruiting)
• CON-10030 Baton Rouge, LA Investigational Site — Baton Rouge, Louisiana, United States (Recruiting)
• CON-10002 Kansas City, MO Investigative Site — Kansas City, Missouri, United States (Recruiting)
• CON-10045 Amarillo, TX Investigational Site — Amarillo, Texas, United States (Recruiting)
• CON-10015 Austin, TX Investigational Site — Austin, Texas, United States (Recruiting)
• CON-21003 Goiania, Goias Investigational Site — Goiânia, Goiás, Brazil (Recruiting)
• CON-21007 Joinville, Santa Catarina Investigational Site — Joinville, Santa Catarina, Brazil (Recruiting)
• CON-21004 Braganca Paulista, Sao Paulo Investigational Site — Bragança Paulista, São Paulo, Brazil (Recruiting)
• CON-21049 Sao Paulo, Sao Paulo Investigational Site — São Paulo, São Paulo, Brazil (Recruiting)
• CON-11012 Surry, BC Investigational Site — Surrey, British Columbia, Canada (Recruiting)
• CON-11007 North York, ON Investigational Site — North York, Ontario, Canada (Recruiting)
• CON-11005 Sherbrooke, QC Investigational Site — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Marc Bonaca

Conditions Heart Failure; Hospitalized