Status:
RECRUITING
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Lead Sponsor:
AstraZeneca
Conditions:
Heart Failure
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
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, a...
Eligibility Criteria
Inclusion Criteria:
-
Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent.
-
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 screening and ≥ 120 mmHg at the Randomisation Visit.
-
At least one additional risk factor for HF:
- Age ≥ 70 years
- 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 Criteria:
- Previously confirmed diagnosis and treatment of heart failure
- An eGFR < 30 mL/min/1.73 m2 at screening
- 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
- Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation
- Myocardial infarction within 3 months prior to randomisation, 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
Key Trial Info
Start Date :
March 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 17 2029
Estimated Enrollment :
11300 Patients enrolled
Trial Details
Trial ID
NCT06677060
Start Date
March 14 2025
End Date
December 17 2029
Last Update
April 3 2026
Active Locations (928)
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1
Research Site
Birmingham, Alabama, United States, 35205
2
Research Site
Centreville, Alabama, United States, 35042
3
Research Site
Fairhope, Alabama, United States, 36532
4
Research Site
Huntsville, Alabama, United States, 35801