A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
Purpose
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.
Condition
- Heart Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Finerenone plus empagliflozin |
|
|
|
No Intervention Usual care |
Usual care management |
|
Recruiting Locations
CON-10004 Fairhope, AL Investigational Site
Fairhope, Alabama 36532
Fairhope, Alabama 36532
Phoenix, AZ Investigative Site CON-10115
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Chula Vista, CA Investigative Site CON-10111
Chula Vista, California 91911
Chula Vista, California 91911
CON-10075 El Centro, CA Investigational Site
El Centro, California 92243
El Centro, California 92243
CON-10024 Sacramento, CA Investigational Site
Sacramento, California 95816
Sacramento, California 95816
San Francisco, CA Investigative Site CON-10315
San Francisco, California 94110
San Francisco, California 94110
CON-10023, San Francisco, CA
San Francisco, California 94118
San Francisco, California 94118
CON-10109, Van Nuys, CA
Van Nuys, California 91405
Van Nuys, California 91405
Bradenton, FL Investigative Site CON-10125
Bradenton, Florida 34209
Bradenton, Florida 34209
Fort Lauderdale, FL Investigative Site CON-10114
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
CON-10022 Atlanta, GA Investigational Site
Atlanta, Georgia 30303
Atlanta, Georgia 30303
CON-10021, Glenview, IL
Glenview, Illinois 60026
Glenview, Illinois 60026
CON-10041, Island Lake, IL
Island Lake, Illinois 60042
Island Lake, Illinois 60042
CON-10025, Naperville, IL
Naperville, Illinois 60540
Naperville, Illinois 60540
CON-10064, Merrillville, IN
Merrillville, Indiana 46410
Merrillville, Indiana 46410
CON-10080, Lexington, KY
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Lexington, KY Investigative Site CON-10118
Lexington, Kentucky 40536
Lexington, Kentucky 40536
CON-10086, Louisville, Kentucky
Louisville, Kentucky 40205
Louisville, Kentucky 40205
CON-10030 Baton Rouge, LA Investigational Site
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
CON-10090, West Monroe, LA
West Monroe, Louisiana 71291
West Monroe, Louisiana 71291
Minneapolis, MN Investigative Site CON-10035
Minneapolis, Minnesota 55417
Minneapolis, Minnesota 55417
CON-10002 Kansas City, MO Investigative Site
Kansas City, Missouri 64111
Kansas City, Missouri 64111
Contact:
Marc Bonaca
Marc Bonaca
CON-10318, Charlotte, NC
Charlotte, North Carolina 28207
Charlotte, North Carolina 28207
Greenville, NC Investigative Site CON-10122
Greenville, North Carolina 27834
Greenville, North Carolina 27834
Morrisville, NC Investigative Site CON-10317
Morrisville, North Carolina 27560
Morrisville, North Carolina 27560
CON-10119, Centerville, OH
Centerville, Ohio 45459
Centerville, Ohio 45459
Philadelphia, PA Investigative Site CON-10068
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
CON-10051, Chattanooga, TN
Chattanooga, Tennessee 37403
Chattanooga, Tennessee 37403
CON-10045 Amarillo, TX Investigational Site
Amarillo, Texas 79106
Amarillo, Texas 79106
CON-10015 Austin, TX Investigational Site
Austin, Texas 78705
Austin, Texas 78705
CON-10301, Fort Worth, TX
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Houston, TX Investigative Site CON-10320
Houston, Texas 77058
Houston, Texas 77058
Texarkana, TX Investigative Site CON-10319
Texarkana, Texas 75503
Texarkana, Texas 75503
Salem, VA Investigative Site CON-10048
Salem, Virginia 24153
Salem, Virginia 24153
More Details
- Status
- Recruiting
- Sponsor
- Colorado Prevention Center
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).