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Clinical Trials in Canada / NCT06033950
Recruiting Phase 3

A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists

NCT06033950 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2024-08-20
Last updated
2026-07-10

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Finerenone →Placebo

Finerenone: Oral finerenone.

Placebo: Matching oral placebo.

Study summary

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

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 * Symptomatic HFrEF per protocol defined criteria * Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment * Negative pregnancy test and agreement to use adequate contraception during trial (female participants only) Exclusion Criteria: * Treatment with non-steroidal MRA (nsMRA) * Documented prior history of severe hyperkalemia in the setting of MRA use * eGFR \< 25 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 or planned * Prior or planned heart transplant * Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure * Symptomatic bradycardia or second- or third-degree heart block without a pacemaker * Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction * Probable alternative cause of participant's HF * Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers * Known hypersensitivity to the IP (active substance or excipients) * Any other condition or therapy which would make the participant unsuitable for the study * Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization

Primary outcome measure(s)

Trial sites (176)

FacilityCityRegionStatus
FIN-10004 Fairhope, AL Investigational Site Fairhope Alabama Recruiting
Phoenix, AZ Investigative Site FIN-10115 Phoenix Arizona Recruiting
FIN-10401, Yuma, AZ Yuma Arizona Recruiting
Chula Vista, CA Investigative Site FIN-10419 Chula Vista California Recruiting
Chula Vista, CA Investigative Site FIN-10111 Chula Vista California Recruiting
FIN-10407, Northridge, CA Northridge California Recruiting
FIN-10412, Orange, CA Orange California Recruiting
FIN-10070, Pamona, CA Pomona California Recruiting
FIN-10024, Sacramento, CA Sacramento California Recruiting
FIN-10406, San Diego, CA San Diego California Recruiting
San Diego, CA Investigative Site FIN-10420 San Diego California Recruiting
FIN-10075 San Diego, CA Investigational Site San Diego California Recruiting
San Francisco, CA Investigative Site FIN-10023 San Francisco California Recruiting
FIN-10423, Sherman Oaks, CA Sherman Oaks California Recruiting
FON-10409, Tarzana, CA Tarzana California Recruiting
FIN-10109, Van Nuys, CA Van Nuys California Recruiting
FIN-10408, West Covina, CA West Covina California Recruiting
FIN-10013, West Hills, CA West Hills California Recruiting
FIN-10110, Aurora, CO Aurora Colorado Recruiting
FIN-10001, Aurora, CO Aurora Colorado Recruiting
Bradenton, FL Investigative Site FIN-10125 Bradenton Florida Recruiting
FIN-10104, Hialeah, FL Hialeah Florida Recruiting
FIN-10028, Jacksonville, FL Jacksonville Florida Recruiting
FIN-10105, Miami, FL Miami Florida Recruiting
FIN-10113, Miramar, FL Miramar Florida Recruiting
FIN-10019, Peoria, IL Peoria Illinois Recruiting
FIN-10064, Merrillville, IN Merrillville Indiana Recruiting
Cynthiana, KY Investigative Site FIN-10124 Cynthiana Kentucky Recruiting
FIN-10080, Lexington, KY Lexington Kentucky Recruiting
Lexington, KY Investigative Site FIN-10118 Lexington Kentucky Recruiting
FIN-10086, Louisville, KY Louisville Kentucky Recruiting
Louisville, KY Investigative Site FIN-10417 Louisville Kentucky Recruiting
FIN-10079, Paducah, KY Paducah Kentucky Recruiting
FIN-10030, Baton Rouge, LA Baton Rouge Louisiana Recruiting
FIN-10106, Hammond, LA Hammond Louisiana Recruiting
FIN-10090, West Monroe, LA West Monroe Louisiana Recruiting
Minneapolis, MN Investigative Site FIN-10035 Minneapolis Minnesota Recruiting
FIN-10002 Kansas City, MO Investigational Site Kansas City Missouri Recruiting
FIN-10318, Charlotte, NC Charlotte North Carolina Recruiting
Greenville, NC Investigative Site FIN-10122 Greenville North Carolina Recruiting

+ 136 more sites — see the full list on the official registry below.

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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 NCT06033950 on ClinicalTrials.gov ↗ ← All trials in Canada