RecruitingPhase 3NCT06033950

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)


Sponsor

Colorado Prevention Center

Enrollment

2,600 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether finerenone, a newer heart medication, can safely help people with heart failure who cannot tolerate the standard class of medications called steroidal mineralocorticoid receptor antagonists (sMRAs). You may be eligible if... - You are 18 or older - You have symptomatic heart failure with reduced ejection fraction (HFrEF) - You cannot take sMRA medications due to intolerance, contraindications, or ineligibility - Women of childbearing potential must use adequate contraception and have a negative pregnancy test You may NOT be eligible if... - You are already taking a non-steroidal MRA - You have a history of severe high potassium while on MRA medications - Your kidney function (eGFR) is below 25 or your potassium is above 5.0 mmol/L - You recently had a heart attack, heart surgery, or device implant (within 30 days) - You have had or are planning a heart transplant - You have serious heart valve disease, abnormal heart rhythms without a pacemaker, or certain types of cardiomyopathy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFinerenone

Oral finerenone.

DRUGPlacebo

Matching oral placebo.


Locations(8)

FIN-10004 Fairhope, AL Investigational Site

Fairhope, Alabama, United States

FIN-10075 San Diego, CA Investigational Site

San Diego, California, United States

FIN-10002 Kansas City, MO Investigational Site

Kansas City, Missouri, United States

FIN-10015 Austin, TX Investigational Site

Austin, Texas, United States

FIN-21003 Goiania, Goias Investigational Site

Goiânia, Goiás, Brazil

FIN-21049 Sao Paulo, Investigational Site

Sao Paulp, Sap Paulo, Brazil

FIN-21004 Braganca Paulista, Investigational Site

Bragança Paulista, São Paulo, Brazil

FIN-11012 Surrey, BC Investigational Site

Surrey, British Columbia, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06033950


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