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A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)
NCT06024746 · Colorado Prevention Center
In plain English
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Official title
Combined Efficacy and Safety of an Early, Intensive, Management Strategy with Finerenone and SGLT2 Inhibitor in Patients Hospitalized with Heart Failure (CONFIRMATION-HF)
About this study
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).
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
Study design
Enrollment target: 1500 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-07-09
Estimated completion: 2026-08
Last updated: 2025-03-11
Interventions
Drug: FinerenoneDrug: Empagliflozin
Primary outcomes
- • Clinical benefit (6 months)
- • Number of serious adverse events (AEs). (6 months)
- • Number of adverse events leading to discontinuation of study drug. (6 months)
Sponsor
Colorado Prevention Center · other
With: Saint Luke's Mid America Heart Institute, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Contacts & investigators
ContactMarc Bonaca · contact · info@cpcmed.org · (303) 860-9900
All locations (15)
CON-10004 Fairhope, AL Investigational SiteRecruiting
Fairhope, Alabama, United States
CON-10075 El Centro, CA Investigational SiteRecruiting
El Centro, California, United States
CON-10024 Sacramento, CA Investigational SiteRecruiting
Sacramento, California, United States
CON-10022 Atlanta, GA Investigational SiteRecruiting
Atlanta, Georgia, United States
CON-10030 Baton Rouge, LA Investigational SiteRecruiting
Baton Rouge, Louisiana, United States
CON-10002 Kansas City, MO Investigative SiteRecruiting
Kansas City, Missouri, United States
CON-10045 Amarillo, TX Investigational SiteRecruiting
Amarillo, Texas, United States
CON-10015 Austin, TX Investigational SiteRecruiting
Austin, Texas, United States
CON-21003 Goiania, Goias Investigational SiteRecruiting
Goiânia, Goiás, Brazil
CON-21007 Joinville, Santa Catarina Investigational SiteRecruiting
Joinville, Santa Catarina, Brazil
CON-21004 Braganca Paulista, Sao Paulo Investigational SiteRecruiting
Bragança Paulista, São Paulo, Brazil
CON-21049 Sao Paulo, Sao Paulo Investigational SiteRecruiting
São Paulo, São Paulo, Brazil
CON-11012 Surry, BC Investigational SiteRecruiting
Surrey, British Columbia, Canada
CON-11007 North York, ON Investigational SiteRecruiting
North York, Ontario, Canada
CON-11005 Sherbrooke, QC Investigational SiteRecruiting
Sherbrooke, Quebec, Canada