A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)
- Registration Number
- NCT06024746
- Lead Sponsor
- Colorado Prevention Center
- Brief Summary
Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Finerenone plus empagliflozin Finerenone - Finerenone plus empagliflozin Empagliflozin -
- Primary Outcome Measures
Name Time Method Clinical benefit 6 months Hierarchical composite of the following:
* Time to all-cause mortality
* Number of total HF events
* Time to first HF event
* Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) assessed by the win-ratio methodNumber of serious adverse events (AEs). 6 months - Serious AEs (excluding efficacy endpoints).
Number of adverse events leading to discontinuation of study drug. 6 months - AEs leading to discontinuation of finerenone or empagliflozin.
- Secondary Outcome Measures
Name Time Method Time to first death from any cause or HF event. 6 months Time to first occurrence of all-cause mortality or HF event (hospitalization for HF or urgent visit due to HF)
Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS). 6 months Number of HF events from baseline to Day 90. 90 days - Total (first and recurrent) HF events.
Trial Locations
- Locations (15)
CON-10004 Fairhope, AL Investigational Site
🇺🇸Fairhope, Alabama, United States
CON-10075 El Centro, CA Investigational Site
🇺🇸El Centro, California, United States
CON-10024 Sacramento, CA Investigational Site
🇺🇸Sacramento, California, United States
CON-10022 Atlanta, GA Investigational Site
🇺🇸Atlanta, Georgia, United States
CON-10030 Baton Rouge, LA Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
CON-10002 Kansas City, MO Investigative Site
🇺🇸Kansas City, Missouri, United States
CON-10045 Amarillo, TX Investigational Site
🇺🇸Amarillo, Texas, United States
CON-10015 Austin, TX Investigational Site
🇺🇸Austin, Texas, United States
CON-21003 Goiania, Goias Investigational Site
🇧🇷Goiania, Goias, Brazil
CON-21007 Joinville, Santa Catarina Investigational Site
🇧🇷Joinville, Santa Catarina, Brazil
CON-21004 Braganca Paulista, Sao Paulo Investigational Site
🇧🇷Braganca Paulista, Sao Paulo, Brazil
CON-21049 Sao Paulo, Sao Paulo Investigational Site
🇧🇷Sao Paulo, Brazil
CON-11012 Surry, BC Investigational Site
🇨🇦Surrey, British Columbia, Canada
CON-11007 North York, ON Investigational Site
🇨🇦North York, Ontario, Canada
CON-11005 Sherbrooke, QC Investigational Site
🇨🇦Sherbrooke, Quebec, Canada