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