Actively Recruiting
Phase III Randomized Study of Baxdrostat and Dapagliflozin Versus Dapagliflozin Alone to Reduce Heart Failure Events and Cardiovascular Death
Led by AstraZeneca · Updated on 2026-05-18
11300
Participants Needed
942
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with elevated systolic blood pressure, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial designed to assess heart failure events and cardiovascular death risks. Participants will be randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Those in the baxdrostat group may have their dose increased if they meet specific criteria. Before randomization, participants not already on SGLT2 inhibitors or treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg daily for 4 to 6 weeks. Study visits are scheduled at 2, 4, 8, 16, and 34 weeks after randomization, then approximately every four months. If a participant stops the blinded study treatment early, they will continue with open-label dapagliflozin unless specific discontinuation criteria are met. During the study, participants will undergo screening assessments, follow-up visits for monitoring, and data collection up to the study closure point based on event rates, which may last up to 38 months. Researchers will measure the occurrence of heart failure events, cardiovascular death, hospitalizations, and other cardiovascular outcomes. Participants will continue with scheduled visits and assessments even if they discontinue the blinded treatment, ensuring ongoing data collection and safety monitoring throughout the study period.
CONDITIONS
Brief Title
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 40 years of age or older at the time of consent
- Diagnosed with type 2 diabetes mellitus requiring treatment
- Established cardiovascular disease, such as ischemic heart disease, cerebrovascular disease, or peripheral arterial disease
- History of hypertension with systolic blood pressure of at least 130 mmHg at screening and at least 120 mmHg at randomization
- Have at least one additional risk factor for heart failure, including age 70 or older, urine albumin-to-creatinine ratio over 20 mg/g, estimated glomerular filtration rate below 60 mL/min/1.73 m2, history of polyvascular disease, atrial fibrillation or flutter, or NT-proBNP over 125 ng/L
You will not qualify if you...
- Previous diagnosis and treatment of heart failure
- Estimated glomerular filtration rate below 30 mL/min/1.73 m2 at screening
- Known hyperkalaemia with potassium levels 5.5 mmol/L or higher within 3 months prior to screening
- Type 1 diabetes or uncontrolled type 2 diabetes with HbA1c greater than 10.5% at screening
- Serum sodium below 135 mmol/L at screening
- Stroke, transient ischemic attack, valve implantation or replacement, carotid surgery or angioplasty, or cardiac surgery within 3 months prior to randomization
- Myocardial infarction within 3 months prior to randomization or within 1 month prior without planned revascularization
- Percutaneous coronary intervention within 1 month prior to randomization
- Severe liver impairment (Child-Pugh Class C)
- Documented adrenal insufficiency
- Dialysis or acute kidney injury within 3 months prior to screening
- Use of prohibited medications during the study period
Research Team
A
AstraZeneca Clinical Study Information Center
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