Recruiting
Phase 3

Finerenone & SGLT2i

Sponsor:

Colorado Prevention Center

Code:

NCT06024746

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Finerenone

Empagliflozin

Study Details

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.

Conditions

Heart Failure

Study ID

NCT06024746

Start date

Jul 9, 2024

Status verified date

Jul, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Finerenone plus empagliflozin

no intervention: Usual care

Usual care management

Interventions

Finerenone

Oral finerenone.

Empagliflozin

Oral empagliflozin.

Primary outcome measure

  • Clinical benefit [ Time Frame: 6 months ]
  • Number of serious adverse events (AEs). [ Time Frame: 6 months ]
  • Number of adverse events leading to discontinuation of study drug. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Marc Bonaca

(303) 860-9900info@cpcmed.org

Locations

CON-10004 Fairhope, AL Investigational Site

Recruiting

Fairhope, Alabama, United States, 36532

CON-10075 El Centro, CA Investigational Site

Recruiting

El Centro, California, United States, 92243

CON-10024 Sacramento, CA Investigational Site

Recruiting

Sacramento, California, United States, 95816

CON-10023, San Francisco, CA

Recruiting

San Francisco, California, United States, 94118

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10109, Van Nuys, CA

Recruiting

Van Nuys, California, United States, 91405

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10001, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10005, Denver, CO

Recruiting

Denver, Colorado, United States, 80204

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10078, Hialeah, FL

Recruiting

Hialeah, Florida, United States, 33012

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10105, Miami, FL

Recruiting

Miami, Florida, United States, 33135

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10113, Miramar, FL

Recruiting

Miramar, Florida, United States, 33027

Contacts

Bonaca, MD

3038609900info@cpcmed.org

CON-10022 Atlanta, GA Investigational Site

Recruiting

Atlanta, Georgia, United States, 30303

CON-10021, Glenview, IL

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10041, Island Lake, IL

Recruiting

Island Lake, Illinois, United States, 60042

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10025, Naperville, IL

Recruiting

Naperville, Illinois, United States, 60540

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10019, Peoria, IL

Recruiting

Peoria, Illinois, United States, 61603

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10064, Merrillville, IN

Recruiting

Merrillville, Indiana, United States, 46410

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10080, Lexington, KY

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10086, Louisville, Kentucky

Recruiting

Louisville, Kentucky, United States, 40205

Contacts

Bonaca, MD

3038609900info@cpcmed.org

CON-10079, Paducah, KY

Recruiting

Paducah, Kentucky, United States, 42003

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10030 Baton Rouge, LA Investigational Site

Recruiting

Baton Rouge, Louisiana, United States, 70808

CON-10090, West Monroe, LA

Recruiting

West Monroe, Louisiana, United States, 71291

Contacts

Bonaca, MD

3038609900info@cpcmed.org

CON-10002 Kansas City, MO Investigative Site

Recruiting

Kansas City, Missouri, United States, 64111

CON-10018, Omaha, NE

Recruiting

Omaha, Nebraska, United States, 68105

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10318, Charlotte, NC

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10119, Centerville, OH

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10051, Chattanooga, TN

Recruiting

Chattanooga, Tennessee, United States, 37403

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10045 Amarillo, TX Investigational Site

Recruiting

Amarillo, Texas, United States, 79106

CON-10015 Austin, TX Investigational Site

Recruiting

Austin, Texas, United States, 78705

CON-10304, Denison, TX

Recruiting

Denison, Texas, United States, 75020

Contacts

Bonaca, MD

3038609900info@cpcmed.org

CON-10301, Fort Worth, TX

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10085, Houston, TX

Recruiting

Houston, Texas, United States, 77030

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-10305, Layton, UT

Recruiting

Layton, Utah, United States, 84041

Contacts

3038609900info@cpcmed.org

CON-10009, Norfolk, VA

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-11011, Edmonton, AB

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-11012 Surry, BC Investigational Site

Recruiting

Surrey, British Columbia, Canada, V3V OC6

CON-11016, Sudbury, ON

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-11010, London, ON

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-11007 North York, ON Investigational Site

Recruiting

North York, Ontario, Canada, M6B 3H7

CON-11008, Toronto, ON

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-11019, Toronto, ON

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-11001, Toronto, ON

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-11026, Montreal, Quebec

Recruiting

Montreal, Quebec, Canada, H2X 1R9

Contacts

Bonaca, MD

+1-303-860-9900info@cpcmed.org

CON-11005 Sherbrooke, QC Investigational Site

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Colorado Prevention Center

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Heart Failure
  • Hospitalized

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Colorado Prevention Center on 2026-07-23.