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Clinical Trials in India / NCT06024746
Recruiting Phase 3

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

NCT06024746 · tracked via the Priya Life Science India tracker
Sponsor
Colorado Prevention Center
Phase
Phase 3
Started
2024-07-09
Last updated
2026-09-10

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

FinerenoneEmpagliflozin

Finerenone: Oral finerenone.

Empagliflozin: Oral empagliflozin.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (140)

FacilityCityRegionStatus
CON-10004 Fairhope, AL Investigational Site Fairhope Alabama Recruiting
Phoenix, AZ Investigative Site CON-10115 Phoenix Arizona Recruiting
Chula Vista, CA Investigative Site CON-10111 Chula Vista California Recruiting
CON-10075 El Centro, CA Investigational Site El Centro California Recruiting
CON-10024 Sacramento, CA Investigational Site Sacramento California Recruiting
San Francisco, CA Investigative Site CON-10315 San Francisco California Recruiting
CON-10023, San Francisco, CA San Francisco California Recruiting
CON-10109, Van Nuys, CA Van Nuys California Recruiting
CON-10001, Aurora, CO Aurora Colorado Recruiting
CON-10005, Denver, CO Denver Colorado Recruiting
Bradenton, FL Investigative Site CON-10125 Bradenton Florida Recruiting
Fort Lauderdale, FL Investigative Site CON-10114 Fort Lauderdale Florida Recruiting
CON-10078, Hialeah, FL Hialeah Florida Recruiting
CON-10105, Miami, FL Miami Florida Recruiting
CON-10113, Miramar, FL Miramar Florida Recruiting
CON-10022 Atlanta, GA Investigational Site Atlanta Georgia Recruiting
CON-10021, Glenview, IL Glenview Illinois Recruiting
CON-10041, Island Lake, IL Island Lake Illinois Recruiting
CON-10025, Naperville, IL Naperville Illinois Recruiting
CON-10019, Peoria, IL Peoria Illinois Recruiting
CON-10064, Merrillville, IN Merrillville Indiana Recruiting
CON-10080, Lexington, KY Lexington Kentucky Recruiting
Lexington, KY Investigative Site CON-10118 Lexington Kentucky Recruiting
CON-10086, Louisville, Kentucky Louisville Kentucky Recruiting
CON-10079, Paducah, KY Paducah Kentucky Recruiting
CON-10030 Baton Rouge, LA Investigational Site Baton Rouge Louisiana Recruiting
CON-10090, West Monroe, LA West Monroe Louisiana Recruiting
Minneapolis, MN Investigative Site CON-10035 Minneapolis Minnesota Recruiting
CON-10002 Kansas City, MO Investigative Site Kansas City Missouri Recruiting
CON-10018, Omaha, NE Omaha Nebraska Recruiting
CON-10318, Charlotte, NC Charlotte North Carolina Recruiting
Greenville, NC Investigative Site CON-10122 Greenville North Carolina Recruiting
Morrisville, NC Investigative Site CON-10317 Morrisville North Carolina Recruiting
CON-10119, Centerville, OH Centerville Ohio Recruiting
Philadelphia, PA Investigative Site CON-10068 Philadelphia Pennsylvania Recruiting
CON-10051, Chattanooga, TN Chattanooga Tennessee Recruiting
CON-10045 Amarillo, TX Investigational Site Amarillo Texas Recruiting
CON-10015 Austin, TX Investigational Site Austin Texas Recruiting
CON-10304, Denison, TX Denison Texas Recruiting
CON-10301, Fort Worth, TX Fort Worth Texas Recruiting

+ 100 more sites — see the full list on the official registry below.

On this site

📄 Jardiance (empagliflozin) drug profile →

More Colorado Prevention Center trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06024746 on ClinicalTrials.gov ↗ ← All trials in India