Comparing 3 approaches for heart failure and impaired kidney function
Official title: Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
- Phase 3
- 3 groups
- Sites in New Westminster, North Vancouver and 19 more cities
- Recruiting
Interventions
- Medication
balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
- Medication
balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
- Medication
dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
Canadian Sites (27)
16 of 27 recruiting
- Recruiting
Research Site
Winnipeg, Manitoba
- Recruiting
Research Site
Sydney, Nova Scotia
- Recruiting
Research Site
Cambridge, Ontario
- Recruiting
Research Site
Hamilton, Ontario
- Recruiting
Research Site
London, Ontario
- Recruiting
Research Site
Newmarket, Ontario
- Recruiting
Research Site
North York, Ontario
- Recruiting
Research Site
Thunder Bay, Ontario
- Recruiting
Research Site
Toronto, Ontario
- Recruiting
Research Site
Waterloo, Ontario
- Recruiting
Research Site
Greenfield Park, Quebec
- Recruiting
Research Site
Montreal, Quebec
- Recruiting
Research Site
Montreal, Quebec
- Recruiting
Research Site
Montreal, Quebec
- Recruiting
Research Site
Trois-Rivières, Quebec
- Recruiting
Research Site
Trois-Rivières, Quebec
- Withdrawn
Research Site
New Westminster, British Columbia
- Withdrawn
Research Site
North Vancouver, British Columbia
- Withdrawn
Research Site
Vancouver, British Columbia
- Completed
Research Site
Cambridge, Ontario
- Withdrawn
Research Site
Oakville, Ontario
- Stopped early
Research Site
Oshawa, Ontario
- Withdrawn
Research Site
Ottawa, Ontario
- Withdrawn
Research Site
Peterborough, Ontario
- Withdrawn
Research Site
Chicoutimi, Quebec
- Withdrawn
Research Site
Montreal, Quebec
- Withdrawn
Research Site
Saint-Jean-sur-Richelieu, Quebec
Eligibility Criteria
See who this study is looking for21 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
- +An eGFR ≥ 20 to \< 60 mL/min/1.73 m2
- +Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
- +Having had a recent HF event within 6 months (hospitalization or urgent visit)
- +Have a LVEF value from an assessment within the last 12 months
- +Managed with SoCStandard of careThe treatment normally given for a condition outside a study.Read more → therapy for HF and renal impairment according to local guidelines
- +NT-proBNP must be \>300 pg/mL (\>600 pg/mL if concomitant atrial fibrillation or atrial flutter)
- +Not taking an MRA
- +Serum/plasma potassium ≤ 5.0 mmol/L
Exclusion
- −Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → or during the screening periodScreeningThe checks done before joining, to see whether a study fits.Read more →
- −History of hypertrophic obstructive cardiomyopathy
- −Complex congenital heart disease or severe uncorrected primary valvular disease
- −Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
- −Systolic BP \< 90 mmHg, or symptomatic hypotension within the past 24 hours
- −Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
- −Type 1 diabetes mellitus
- −Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
- −Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy
- −Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
- −Treatment with strong or moderate CYP3A4 inhibitor or inducer
- −Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations
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.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives balcinrenone/dapagliflozin 15 mg/10 mg and matching placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → for dapagliflozin 10 mg.
Registry label: A: balcinrenone/dapagliflozin 15 mg/10 mg
Group B receives balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg.
Registry label: B: balcinrenone/dapagliflozin 40 mg/10 mg
Group C, the comparison group, receives dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin.
Registry label: C: dapagliflozin 10 mg
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
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 — alongside the other treatment that group is given.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 130 years.
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.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 3,850 people.
The study is currently expected to finish around April 2027.
The main measurement is taken over: Approximately 36 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 any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation — measured over Approximately 36 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06307652 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 balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mgDrug
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
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 balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mgDrug
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
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 dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozinDrug
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
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: an age range of 18 years to 130 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.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. 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 — alongside the other treatment that group is given.
One group receives an existing treatment so the two can be compared.
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 an age range of 18 years to 130 years.
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.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Approximately 36 months.
The study as a whole is currently expected to finish around 2027-04-16.
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 3,850 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 43 locations, including: New Westminster, British Columbia, Canada; North Vancouver, British Columbia, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Sydney, Nova Scotia, Canada; Cambridge, Ontario, Canada, and 37 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
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
Other Sites (23)
Research Site
Ann Arbor, Michigan, United States
Research Site
Bloomfield Hills, Michigan, United States
Research Site
Dearborn, Michigan, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
Flint, Michigan, United States
Research Site
Troy, Michigan, United States
Research Site
Ypsilanti, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Saint Paul, Minnesota, United States
Research Site
Albany, New York, United States
Research Site
Brooklyn, New York, United States
Research Site
Brooklyn, New York, United States
Research Site
Clifton Park, New York, United States
Research Site
Manhasset, New York, United States
Research Site
New Windsor, New York, United States
Research Site
New York, New York, United States
Research Site
Staten Island, New York, United States
Research Site
Stony Brook, New York, United States
Research Site
The Bronx, New York, United States
Research Site
The Bronx, New York, United States
And 3 more sites worldwide.
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.