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
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
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well finerenone works and how safe it is compared with a placebo (a treatment with no active drug). It is for adults with heart failure whose heart pumps less blood than normal and who cannot take certain heart drugs called steroidal MRAs.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Give written or electronic consent to join, yourself or through a legally approved representative.
- Be at least 18, or the legal adult age in your country if that is older.
- Have heart failure symptoms and reduced heart pumping that meet the study’s rules.
- Not take steroidal MRA drugs because of past side effects or another reason you cannot use them.
- For female participants: have a negative pregnancy test and agree to use suitable birth control during the study.
Who can't join
- Take a non-steroidal MRA drug; have had very high blood potassium while taking an MRA; or have a kidney filtering score (eGFR) below 25 or blood potassium above 5.0 mmol/L.
- Have had a heart attack, a procedure to restore blood flow to the heart, heart valve repair or replacement, or a device placed to help the heart beat in sync within 30 days, or have one planned. A past or planned heart transplant also rules you out.
- Have a severe, uncorrected heart valve problem that the study doctor thinks is the main cause of heart failure; or have a slow heartbeat causing symptoms or certain blocked heart signals without a pacemaker.
- Have certain heart muscle diseases linked to sudden heart inflammation, substances building up in the heart, muscular dystrophy, or a cause that can be reversed. Other excluded problems include thick heart muscle blocking blood flow, complex heart defects present at birth, or a stiff sac around the heart.
- Have another likely cause of heart failure, or another health condition or treatment that makes the study unsuitable for you.
- Take certain medicines that strongly block, or moderately or strongly speed up, a liver enzyme called CYP3A4 that breaks down drugs.
- Have a known allergy to the study drug or any of its ingredients.
- Take part in another treatment study using an experimental drug now, or within 30 days before being assigned to a study group.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (54)
AL
- FIN-10004 Fairhope, AL Investigational Site · Fairhope, AL 36532Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Fairhope
AZ
- Phoenix, AZ Investigative Site FIN-10115 · Phoenix, AZ 85006Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Phoenix
- FIN-10401, Yuma, AZ · Yuma, AZ 85365Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Yuma
CA
- Chula Vista, CA Investigative Site FIN-10419 · Chula Vista, CA 91910Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Chula Vista
- Chula Vista, CA Investigative Site FIN-10111 · Chula Vista, CA 91911Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Chula Vista
- FIN-10407, Northridge, CA · Northridge, CA 91324Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Northridge
- FIN-10412, Orange, CA · Orange, CA 92866Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Orange
- FIN-10070, Pamona, CA · Pomona, CA 91767Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Pomona
- FIN-10024, Sacramento, CA · Sacramento, CA 95816Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Sacramento
- FIN-10406, San Diego, CA · San Diego, CA 91127Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in San Diego
- San Diego, CA Investigative Site FIN-10420 · San Diego, CA 92111Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in San Diego
- FIN-10075 San Diego, CA Investigational Site · San Diego, CA 92243Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in San Diego
- San Francisco, CA Investigative Site FIN-10023 · San Francisco, CA 94118Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in San Francisco
- FIN-10423, Sherman Oaks, CA · Sherman Oaks, CA 91403Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Sherman Oaks
- FON-10409, Tarzana, CA · Tarzana, CA 91356Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Tarzana
- FIN-10109, Van Nuys, CA · Van Nuys, CA 91405Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Van Nuys
- FIN-10408, West Covina, CA · West Covina, CA 91790Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in West Covina
- FIN-10013, West Hills, CA · West Hills, CA 91307Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in West Hills
CO
- FIN-10110, Aurora, CO · Aurora, CO 80012Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Aurora
- FIN-10001, Aurora, CO · Aurora, CO 80045Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Aurora
FL
- Bradenton, FL Investigative Site FIN-10125 · Bradenton, FL 34209Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Bradenton
- FIN-10104, Hialeah, FL · Hialeah, FL 33012Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Hialeah
- FIN-10028, Jacksonville, FL · Jacksonville, FL 32209Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Jacksonville
- FIN-10105, Miami, FL · Miami, FL 33135Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Miami
- FIN-10113, Miramar, FL · Miramar, FL 33027Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Miramar
IL
- FIN-10019, Peoria, IL · Peoria, IL 61603Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Peoria
IN
- FIN-10064, Merrillville, IN · Merrillville, IN 46410Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Merrillville
KY
- Cynthiana, KY Investigative Site FIN-10124 · Cynthiana, KY 41031Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Cynthiana
- FIN-10080, Lexington, KY · Lexington, KY 40503Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Lexington
- Lexington, KY Investigative Site FIN-10118 · Lexington, KY 40536Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Lexington
- FIN-10086, Louisville, KY · Louisville, KY 40205Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Louisville
- Louisville, KY Investigative Site FIN-10417 · Louisville, KY 40205Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Louisville
- FIN-10079, Paducah, KY · Paducah, KY 42003Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Paducah
LA
- FIN-10030, Baton Rouge, LA · Baton Rouge, LA 70808Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Baton Rouge
- FIN-10106, Hammond, LA · Hammond, LA 70403Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Hammond
- FIN-10090, West Monroe, LA · West Monroe, LA 71291Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in West Monroe
MN
- Minneapolis, MN Investigative Site FIN-10035 · Minneapolis, MN 55417Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Minneapolis
MO
- FIN-10002 Kansas City, MO Investigational Site · Kansas City, MO 64111Bonaca · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Kansas City
NC
- FIN-10318, Charlotte, NC · Charlotte, NC 28207Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Charlotte
- Greenville, NC Investigative Site FIN-10122 · Greenville, NC 27834Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Greenville
OH
- FIN-10081, Akron, OH · Akron, OH 44304Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Akron
- FIN-10119, Centerville, OH · Centerville, OH 45459Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Centerville
- FIN- 10112, Cincinnati, OH · Cincinnati, OH 45219Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Cincinnati
SC
- Orangeburg, SC Investigative Site FIN-10433 · Orangeburg, SC 29118Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Orangeburg
TX
- FIN-10015 Austin, TX Investigational Site · Austin, TX 78705Bonaca · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Austin
- FIN-10404, Denison, TX · Denison, TX 75020Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Denison
- FIN-10085, Houston, TX · Houston, TX 77030Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Houston
- Tyler, TX Investigative Site FIN-10422 · Tyler, TX 75702Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Tyler
UT
- FIN-10405, Layton, UT · Layton, UT 84041Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Layton
VA
- FIN-10402, Norfolk, VA · Norfolk, VA 23510Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Norfolk
- FIN-10093, Richmond, VA · Richmond, VA 23298-5051Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Richmond
- Salem, VA Investigative Site FIN-10048 · Salem, VA 24153Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Salem
VT
- FIN-10053, Burlington, VT · Burlington, VT 05401Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Burlington
WI
- Milwaukee, WI Investigative Site FIN-10428 · Milwaukee, WI 53215Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Milwaukee