Testing Finerenone against a placebo for heart failure
Official title: A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF)
Interventions
Finerenone
Oral finerenone
Placebo
Matching oral placebo
Canadian Sites (17)
Calgary, AB Investigative Site 11009
Calgary, Alberta, Canada
Edmonton, AB Investigative Site 11018
Edmonton, Alberta, Canada
Edmonton, Alberta Investigative Site 11011
Edmonton, Alberta, Canada
Kamloops, BC Investigative Site 11021
Kamloops, British Columbia, Canada
North Vancouver, BC Investigative Site11020
North Vancouver, British Columbia, Canada
Surrey, British Columbia Investigative Site 11012
Surrey, British Columbia, Canada
Vancouver, BC Investigative Site 11017
Vancouver, British Columbia, Canada
Winnipeg, MB Investigative Site 11006
Winnipeg, Manitoba, Canada
Cambridge, ON Investigative Site 11003
Cambridge, Ontario, Canada
Sudbury, ON Investigative Site 11016
Greater Sudbury, Ontario, Canada
London, ON Investigative Site 11010
London, Ontario, Canada
North York, Ontario Investigative Site 11007
North York, Ontario, Canada
Toronto, Ontario Investigative Site 11008
Toronto, Ontario, Canada
Toronto, ON Investigative Site 11019
Toronto, Ontario, Canada
Toronto, ON Investigative Site 11001
Toronto, Ontario, Canada
Sherbrooke, QC Investigative Site 11005
Sherbrooke, Quebec, Canada
Regina, SK Investigative Site 11022
Regina, Saskatchewan, Canada
Eligibility Criteria
See who this study is looking for15 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 written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure
- +Heart failure signs and symptoms at the time of hospital admission
- +Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
- +Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF
Exclusion
- −Known hypersensitivity to the IP (active substance or excipients)
- −Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)
- −Documented prior history of severe hyperkalemia in the setting of MRA use
- −Estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m² or potassium \>5.0 mmol/L at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
- −Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
- −Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction
- −Probable alternative cause of participant's heart failure symptoms
- −Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
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 5,200 people.
The study is currently expected to finish around December 2027.
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
Composite of total HF events and cardiovascular (CV) death — 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: NCT06008197 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 2027-12.
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 5,200 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 18 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Kamloops, British Columbia, Canada; North Vancouver, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada, and 12 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 hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
Other Sites (5)
Minneapolis, MN Investigative Site 10091
Minneapolis, Minnesota, United States
Minneapolis, MN Investigative Site 10035
Minneapolis, Minnesota, United States
Roslyn, NY Investigative Site 10058
Roslyn, New York, United States
Stony Brook, NY Investigative Site 10017
Stony Brook, New York, United States
Spokane, WA Investigative Site 10123
Spokane, Washington, 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.