NCT06033950 · Colorado Prevention Center
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
(FINALITY-HF)
What this study is about
Finerenone will be compared to placebo to determine effectiveness 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).
View original scientific 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).
Interventions
DRUG
Finerenone
Oral finerenone.
DRUG
Placebo
Matching oral placebo.
Primary outcome measures
Time to first occurrence of cardiovascular (CV) death or HF event.
Time frame: Ongoing, up to ~30 months
\- Time to first CV death or HF event with finerenone compared to placebo.
Number of serious adverse events
Time frame: Ongoing, up to ~30 months
\- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Number of adverse events leading to discontinuation of study drug.
Time frame: Ongoing, up to ~30 months
\- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 v
Where
- Fairhope, Alabama
- Phoenix, Arizona
- Yuma, Arizona
- Chula Vista, California
- Northridge, California
- Orange, California
- Pomona, California
- Sacramento, California
- San Diego, California
- San Francisco, California
- Sherman Oaks, California
- Tarzana, California
And 36 more locations — see the full list below.
Collaborators
St. Luke's Hospital, Kansas City, Missouri, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations