Testing Finerenone against a placebo for heart failure
Official 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
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)
Interventions
Finerenone
Oral finerenone.
Placebo
Matching oral placebo.
Canadian Sites (14)
Calgary, AB Investigative Site FIN-11009
Calgary, Alberta, Canada
FIN-11028, Edmonton, AB
Edmonton, Alberta, Canada
FIN-11011, Edmonton, AB
Edmonton, Alberta, Canada
FIN-11020, North Vancouver, BC
North Vancouver, British Columbia, Canada
FIN-11012 Surrey, BC Investigational Site
Surrey, British Columbia, Canada
FIN-11025, Victoria, BC
Victoria, British Columbia, Canada
FIN-11006, Winnipeg, MB
Winnipeg, Manitoba, Canada
FIN-11016, Sudbury, ON
Greater Sudbury, Ontario, Canada
FIN-11024, Kingston, ON
Kingston, Ontario, Canada
FIN-11010, London, ON
London, Ontario, Canada
FIN-11007, North York, ON
North York, Ontario, Canada
FIN-11008, Toronto, ON
Toronto, Ontario, Canada
FIN-11019, Toronto, ON
Toronto, Ontario, Canada
FIN-11005, Sherbrooke, QC
Sherbrooke, Quebec, Canada
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
- +Provide electronic or written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, either personally or through a legally authorized representative, as permitted by local regulations
- +Symptomatic HFrEF per protocolProtocolThe detailed plan a study must follow.Read more → 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
- −Known hypersensitivity to the IP (active substance or excipients)
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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
- −Any other condition or therapy which would make the participant unsuitable for the study
- −Concurrent or previous participation in another interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical study using an investigational agent within 30 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Finerenone, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,600 people.
The study is currently expected to finish around January 2028.
The main measurement is taken over: Ongoing, up to ~30 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to first occurrence of cardiovascular (CV) death or HF event — measured over Ongoing, up to ~30 months.
Number of serious adverse eventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → — measured over Ongoing, up to ~30 months.
Number of adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → leading to discontinuation of study drug — measured over Ongoing, up to ~30 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06033950 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About FinerenoneDrug
Oral finerenone.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Matching oral placebo.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Ongoing, up to ~30 months.
The study as a whole is currently expected to finish around 2028-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,600 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 13 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; North Vancouver, British Columbia, Canada; Surrey, British Columbia, Canada; Victoria, British Columbia, Canada; Winnipeg, Manitoba, Canada, and 7 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
Other Sites (1)
Minneapolis, MN Investigative Site FIN-10035
Minneapolis, Minnesota, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.