A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)
NCT ID: NCT06024746
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1500 participants
INTERVENTIONAL
2024-07-09
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Finerenone plus empagliflozin
Finerenone
Oral finerenone.
Empagliflozin
Oral empagliflozin.
Usual care
Usual care management
No interventions assigned to this group
Interventions
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Finerenone
Oral finerenone.
Empagliflozin
Oral empagliflozin.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Saint Luke's Mid America Heart Institute
UNKNOWN
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
INDUSTRY
Colorado Prevention Center
OTHER
Responsible Party
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Locations
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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
Goiânia, Goiás, Brazil
CON-21007 Joinville, Santa Catarina Investigational Site
Joinville, Santa Catarina, Brazil
CON-21004 Braganca Paulista, Sao Paulo Investigational Site
Bragança Paulista, São Paulo, Brazil
CON-21049 Sao Paulo, Sao Paulo Investigational Site
São Paulo, São 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
Countries
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Central Contacts
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Facility Contacts
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Marc Bonaca
Role: primary
Other Identifiers
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202303CPC
Identifier Type: -
Identifier Source: org_study_id
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