RecruitingPhase 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

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

AZ

CA

CO

FL

IL

IN

KY

LA

MN

MO

NC

OH

SC

TX

UT

VA

VT

WI