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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2025 by Colorado Prevention Center
Sponsor
Colorado Prevention Center
Information Provided by (Responsible Party)
Colorado Prevention Center
Clinicaltrials.gov Identifier
NCT06024746
Other Study ID Numbers:
202303CPC
First Submitted
August 21, 2023
First Posted
September 5, 2023
Last Update Posted
March 10, 2025
Last Verified
February 2025

ClinicalTrials.gov processed this data on March 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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).

Condition or DiseaseIntervention/Treatment
Heart Failure
Drug: Finerenone

Study Design

Study TypeInterventional
Actual Enrollment1500 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleCombined Efficacy and Safety of an Early, Intensive, Management Strategy with Finerenone and SGLT2 Inhibitor in Patients Hospitalized with Heart Failure (CONFIRMATION-HF)
Study Start DateJuly 8, 2024
Actual Primary Completion Date1mo 2w from now
Actual Study Completion Date2mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Finerenone plus empagliflozin
Drug: Finerenone
Oral finerenone.
Usual care
Usual care management

Outcome Measures

Primary Outcome Measures
  1. Clinical benefit
    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 method
  2. Number of serious adverse events (AEs).
    \- Serious AEs (excluding efficacy endpoints).
  3. Number of adverse events leading to discontinuation of study drug.
    \- AEs leading to discontinuation of finerenone or empagliflozin.
Secondary Outcome Measures
  1. Time to first death from any cause or HF event.
    Time to first occurrence of all-cause mortality or HF event (hospitalization for HF or urgent visit due to HF)
  2. Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).
  3. Number of HF events from baseline to Day 90.
    \- Total (first and recurrent) HF events.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsColorado Prevention Center
Locations
CON-10004 Fairhope, AL Investigational Site | Fairhope Alabama, United States, 36532CON-10075 El Centro, CA Investigational Site | El Centro California, United States, 92243CON-10024 Sacramento, CA Investigational Site | Sacramento California, United States, 95816CON-10022 Atlanta, GA Investigational Site | Atlanta Georgia, United States, 30303CON-10030 Baton Rouge, LA Investigational Site | Baton Rouge Louisiana, United States, 70808CON-10002 Kansas City, MO Investigative Site | Kansas City Missouri, United States, 64111CON-10045 Amarillo, TX Investigational Site | Amarillo Texas, United States, 79106CON-10015 Austin, TX Investigational Site | Austin Texas, United States, 78705CON-21003 Goiania, Goias Investigational Site | Goiânia Goiás, Brazil, 74453-200CON-21007 Joinville, Santa Catarina Investigational Site | Joinville Santa Catarina, Brazil, 89200-000CON-21004 Braganca Paulista, Sao Paulo Investigational Site | Bragança Paulista São Paulo, Brazil, 12916542CON-21049 Sao Paulo, Sao Paulo Investigational Site | São Paulo São Paulo, Brazil, 05652-900CON-11012 Surry, BC Investigational Site | Surrey British Columbia, Canada, V3V OC6CON-11007 North York, ON Investigational Site | North York Ontario, Canada, M6B 3H7CON-11005 Sherbrooke, QC Investigational Site | Sherbrooke Quebec, Canada, J1H 5N4