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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

RecruitingPhase 3

A Randomized, Double-blind, Placebo-controlled Pragmatic Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure and Reduced Ejection Fraction Who Are Intolerant of or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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).

What is being tested

Sponsor: Colorado Prevention Center · Participants: 2,600 · Started: Aug 20, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06033950

Locations in the U.S.

AlabamaFIN-10004 Fairhope, AL Investigational Site, Fairhope
ArizonaPhoenix, AZ Investigative Site FIN-10115, Phoenix
FIN-10401, Yuma, AZ, Yuma
CaliforniaChula Vista, CA Investigative Site FIN-10111, Chula Vista
Chula Vista, CA Investigative Site FIN-10419, Chula Vista
FIN-10407, Northridge, CA, Northridge
FIN-10412, Orange, CA, Orange
FIN-10070, Pamona, CA, Pomona
FIN-10024, Sacramento, CA, Sacramento
FIN-10075 San Diego, CA Investigational Site, San Diego
FIN-10406, San Diego, CA, San Diego
San Diego, CA Investigative Site FIN-10420, San Diego
San Francisco, CA Investigative Site FIN-10023, San Francisco
FIN-10423, Sherman Oaks, CA, Sherman Oaks
FON-10409, Tarzana, CA, Tarzana
FIN-10109, Van Nuys, CA, Van Nuys
FIN-10408, West Covina, CA, West Covina
FIN-10013, West Hills, CA, West Hills
ColoradoFIN-10001, Aurora, CO, Aurora
FIN-10110, Aurora, CO, Aurora
FloridaBradenton, FL Investigative Site FIN-10125, Bradenton
FIN-10104, Hialeah, FL, Hialeah
FIN-10028, Jacksonville, FL, Jacksonville
FIN-10105, Miami, FL, Miami
FIN-10113, Miramar, FL, Miramar
IllinoisFIN-10019, Peoria, IL, Peoria
IndianaFIN-10064, Merrillville, IN, Merrillville
KentuckyCynthiana, KY Investigative Site FIN-10124, Cynthiana
FIN-10080, Lexington, KY, Lexington
Lexington, KY Investigative Site FIN-10118, Lexington
FIN-10086, Louisville, KY, Louisville
Louisville, KY Investigative Site FIN-10417, Louisville
FIN-10079, Paducah, KY, Paducah
LouisianaFIN-10030, Baton Rouge, LA, Baton Rouge
FIN-10106, Hammond, LA, Hammond
FIN-10090, West Monroe, LA, West Monroe
MinnesotaMinneapolis, MN Investigative Site FIN-10035, Minneapolis
MissouriFIN-10002 Kansas City, MO Investigational Site, Kansas City
North CarolinaFIN-10318, Charlotte, NC, Charlotte
Greenville, NC Investigative Site FIN-10122, Greenville
OhioFIN-10081, Akron, OH, Akron
FIN-10119, Centerville, OH, Centerville
FIN- 10112, Cincinnati, OH, Cincinnati
South CarolinaOrangeburg, SC Investigative Site FIN-10433, Orangeburg
TexasFIN-10015 Austin, TX Investigational Site, Austin
FIN-10404, Denison, TX, Denison
FIN-10085, Houston, TX, Houston
Tyler, TX Investigative Site FIN-10422, Tyler
UtahFIN-10405, Layton, UT, Layton
VermontFIN-10053, Burlington, VT, Burlington
VirginiaFIN-10402, Norfolk, VA, Norfolk
FIN-10093, Richmond, VA, Richmond
Salem, VA Investigative Site FIN-10048, Salem
WisconsinMilwaukee, WI Investigative Site FIN-10428, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.