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Clinical Trials in India / NCT06008197
Recruiting Phase 3

A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

NCT06008197 · tracked via the Priya Life Science India tracker
Sponsor
Colorado Prevention Center
Phase
Phase 3
Started
2024-01-17
Last updated
2026-09-10

Condition(s) studied

Heart FailureAcute Heart Failure

Investigational drug(s) / intervention(s)

FinerenonePlacebo

Finerenone: Oral finerenone

Placebo: Matching oral placebo

Study summary

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Provide written informed consent * Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence * Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure * Heart failure signs and symptoms at the time of hospital admission * Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher) * Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF Exclusion Criteria: * Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA) * Documented prior history of severe hyperkalemia in the setting of MRA use * Estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m² or potassium \>5.0 mmol/L at screening * Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days * Hemodynamically significant (severe) uncorrected primary cardiac valvular disease * Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known 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)

Primary outcome measure(s)

Trial sites (356)

FacilityCityRegionStatus
Birmingham, AL Investigative Site 10012 Birmingham Alabama Recruiting
Fairhope, AL Investigative Site 10004 Fairhope Alabama Recruiting
Huntsville, AL Investigative Site 10026 Huntsville Alabama Recruiting
Glendale, AZ Investigative Site 10096 Glendale Arizona Recruiting
Phoenix, AZ Investigative Site 10115 Phoenix Arizona Recruiting
Scottsdale, AZ Investigative Site 10003 Scottsdale Arizona Recruiting
Chula Vista, CA Investigative Site 10111 Chula Vista California Recruiting
Huntington Beach, CA Investigative Site 10031 Huntington Beach California Recruiting
Los Angeles, CA Investigative Site 10089 Los Angeles California Recruiting
Sacramento, CA Investigative Site 10024 Sacramento California Recruiting
San Francisco, CA Investigative Site 10023 San Francisco California Recruiting
Tarzana, CA Investigative Site 10409 Tarzana California Recruiting
Van Nuys, CA Investigative Site 10109 Van Nuys California Recruiting
West Hills, CA Investigative Site 10013 West Hills California Recruiting
Aurora, CO Investigative Site 10001 Aurora Colorado Recruiting
Denver, CO Investigative Site 10005 Denver Colorado Recruiting
Bradenton, FL Investigative Site 10125 Bradenton Florida Recruiting
Brooksville, FL Investigative Site 10077 Brooksville Florida Recruiting
Fort Lauderdale, FL Investigative Site 10114 Fort Lauderdale Florida Recruiting
Fort Myers, FL Investigative Site 10076 Fort Myers Florida Recruiting
Hialeah, FL Investigative Site 10104 Hialeah Florida Recruiting
Jacksonville, FL Investigative Site 10028 Jacksonville Florida Recruiting
Miami, FL Investigative Site 10105 Miami Florida Recruiting
Miami, FL Investigative Site 10040 Miami Florida Recruiting
Miramar, FL Investigative Site 10113 Miramar Florida Not Yet Recruiting
Tamarac, Florida Investigative Site 10127 Tamarac Florida Recruiting
Atlanta, GA Investigative Site 10022 Atlanta Georgia Recruiting
Duluth, GA Investigative Site 10083 Duluth Georgia Recruiting
Boise, Idaho Investigative Site 10073 Boise Idaho Recruiting
Chicago, IL Investigative Site 10062 Chicago Illinois Recruiting
Glenview, IL Investigative Site 10021 Glenview Illinois Recruiting
Naperville, IL Investigative Site 10025 Naperville Illinois Recruiting
Peoria, IL Investigative Site 10019 Peoria Illinois Recruiting
Peoria, IL Investigative Site 10010 Peoria Illinois Recruiting
Indianapolis, IN Investigative Site 10074 Indianapolis Indiana Recruiting
Indianapolis, IN Investigative Site 10008 Indianapolis Indiana Recruiting
Merrillville, IN Investigative Site 10064 Merrillville Indiana Recruiting
Kansas City, KS Investigative Site 10060 Kansas City Kansas Recruiting
Cynthiana, KY Investigative Site 10124 Cynthiana Kentucky Recruiting
Lexington, KY Investigative Site 10080 Lexington Kentucky Recruiting

+ 316 more sites — see the full list on the official registry below.

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 NCT06008197 on ClinicalTrials.gov ↗ ← All trials in India