Finerenone Compared With Placebo in Heart Failure Patients
Tests finerenone against placebo in adults with reduced-ejection-fraction heart failure who cannot take steroidal drugs.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Budapest, Gyöngyös, Nyíregyháza, and Pécs, HungarySee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with symptomatic heart failure with reduced ejection fraction who cannot take steroidal mineralocorticoid receptor antagonists (sMRA). Finerenone is compared with placebo.
- Age
- 18 years or older (or the legal age of majority in the country).
- Sex
- All sexes. Female participants need a negative pregnancy test and must agree to use adequate contraception.
- Disease stage
- Symptomatic heart failure with reduced ejection fraction (HFrEF), as defined in the trial protocol.
- Earlier treatment
- Not on sMRA because of past intolerance, a contraindication, or ineligibility for it. Cannot be on non-steroidal MRA (nsMRA).
Main reasons for not taking part
- Treatment with non-steroidal MRA (nsMRA)
- Prior severe high potassium (hyperkalemia) when taking an MRA
- eGFR below 25 mL/min/1.73m² and/or potassium above 5.0 mmol/L
- Heart attack, coronary revascularization, valve replacement/repair or a CRT device within 30 days or planned
- Prior or planned heart transplant
Read by machine on 12 November 2026.
Where in Hungary
- Budapest Investigative Site FIN-34001Budapest, HungaryContact: Marc Bonaca, MDTaking people
- Gyöngyös Investigative Site FIN-34011Gyöngyös, HungaryContact: Marc Bonaca, MDTaking people
- FIN-34004, Nyiregyhaza, HungaryNyíregyháza, HungaryContact: Bonaca, MDTaking people
- Pecs Investigative Site FIN-34006Pécs, HungaryContact: Marc Bonaca, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Colorado Prevention Center
- Trial code
- NCT06033950
- Record updated
- 10 July 2026
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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: Treatment with non-steroidal MRA (nsMRA); Documented prior history of severe hyperkalemia in the setting of MRA use; Prior or planned heart transplant; Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers; Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization; Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned; 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; Known hypersensitivity to the IP (active substance or excipients); Any other condition or therapy which would make the participant unsuitable for the study; eGFR < 25 mL/min/1.73m² and / or potassium > 5.0 mmol/L; Probable alternative cause of participant's HF.