Testing Baxdrostat and dapagliflozin for heart failure
Official title: Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death
- Phase 3
- 2 groups
- Sites in Calgary, Sherwood Park and 26 more cities
- Recruiting
Interventions
- Medication
Baxdrostat and dapagliflozin
baxdrostat tablet and dapagliflozin tablet
- Other intervention
Placebo and dapagliflozin
placebo tablet and dapagliflozin tablet
Canadian Sites (37)
34 of 37 recruiting
- Recruiting
Research Site
Calgary, Alberta
- Recruiting
Research Site
Calgary, Alberta
- Recruiting
Research Site
Sherwood Park, Alberta
- Recruiting
Research Site
Abbotsford British Columbia, British Columbia
- Recruiting
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Moncton, New Brunswick
- Recruiting
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Saint John, New Brunswick
- Recruiting
Research Site
St. John's, Newfoundland and Labrador
- Recruiting
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Halifax, Nova Scotia
- Recruiting
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Sydney, Nova Scotia
- Recruiting
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Guelph, Ontario
- Recruiting
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Hamilton, Ontario
- Recruiting
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Hamilton, Ontario
- Recruiting
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Markham, Ontario
- Recruiting
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Newmarket, Ontario
- Recruiting
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North York, Ontario
- Recruiting
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Oakville, Ontario
- Recruiting
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Ottawa, Ontario
- Recruiting
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Sarnia, Ontario
- Recruiting
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Scarborough Village, Ontario
- Recruiting
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Toronto, Ontario
- Recruiting
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Toronto, Ontario
- Recruiting
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Toronto, Ontario
- Recruiting
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Laval, Quebec
- Recruiting
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Lévis, Quebec
- Recruiting
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Mirabel, Quebec
- Recruiting
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Montreal, Quebec
- Recruiting
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Montreal, Quebec
- Recruiting
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Québec, Quebec
- Recruiting
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Québec, Quebec
- Recruiting
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Saint-Charles-Borromée, Quebec
- Recruiting
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Sherbrooke, Quebec
- Recruiting
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Terrebonne, Quebec
- Recruiting
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Trois-Rivières, Quebec
- Recruiting
Research Site
Regina, Saskatchewan
- Withdrawn
Research Site
Cambridge, Ontario
- Withdrawn
Research Site
North York, Ontario
- Withdrawn
Research Site
Toronto, Ontario
Eligibility Criteria
See who this study is looking for24 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 70 years
- +Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Diagnosed with T2DM and requiring treatment
- +Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)
- +History of HTN and an SBP ≥ 130 mmHg at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → and ≥ 120 mmHg at the RandomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → Visit.
- +At least one additional risk factor for HF:
- +UACR \> 20 mg/g
- +eGFR \< 60 mL/min/1.73 m2
- +History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)
- +History of atrial fibrillation or atrial flutter
- +NT-proBNP \> 125 ng/L
Exclusion
- −Previously confirmed diagnosis and treatment of heart failure
- −An eGFR \< 30 mL/min/1.73 m2 at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening
- −Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) at screening
- −Serum sodium \< 135 mmol/L at screening, determined as per central laboratory assessment
- −Myocardial infarction within 3 months prior to randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, or within 1 month prior to randomisation when there is no further planned revascularisation
- −Percutaneous coronary intervention within 1 month prior to randomisation
- −Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
- −Documented history of adrenal insufficiency
- −Any dialysis (including for acute kidney injury) within 3 months prior to screening
- −Any acute kidney injury within 3 months prior to screening
- −Prohibited concomitant medications
- −Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation
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 way to prevent a condition from developing.
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 2 groups in this study.
Group A receives Baxdrostat and dapagliflozin.
Registry label: A: Baxdrostat/Dapagliflozin
Group B receives PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → and dapagliflozin.
Registry label: B: Placebo/Dapagliflozin
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.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 40 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 11,300 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: Event driven; Up to 38 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
To determine if baxdrostat/dapagliflozin is superior to placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →/dapagliflozin in reducing the risk of an HF event or CV death — measured over Event driven; Up to 38 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06677060 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 Baxdrostat and dapagliflozinDrug
baxdrostat tablet and dapagliflozin tablet
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 Placebo and dapagliflozinOther
placebo tablet and dapagliflozin tablet
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
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 40 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. 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.
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 40 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: Event driven; Up to 38 months.
The study as a whole is currently expected to finish around 2029-12-17.
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 11,300 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 45 locations, including: Calgary, Alberta, Canada; Sherwood Park, Alberta, Canada; Abbotsford British Columbia, British Columbia, Canada; Moncton, New Brunswick, Canada; Saint John, New Brunswick, Canada; St. John's, Newfoundland and Labrador, Canada, and 39 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
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.
Other Sites (18)
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
Mankato, Minnesota, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Kalispell, Montana, United States
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Missoula, Montana, United States
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Albany, New York, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Massapequa, New York, United States
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New York, New York, United States
Research Site
Queens Village, New York, United States
Research Site
Puyallup, Washington, United States
Research Site
Redmond, Washington, United States
Research Site
Renton, Washington, United States
If this study interests you
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This 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.