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Phase III Study of Baxdrostat and Dapagliflozin for Heart Failure

This study is looking at whether combining two medications, baxdrostat and dapagliflozin, can better reduce the risk of heart failure (HF) events or death from heart problems compared to dapagliflozin alone with a placebo. You may be able to join if you are at least 40 years old, have type 2 diabetes (T2DM), existing cardiovascular disease, and high blood pressure (hypertension or HTN) with a systolic blood pressure (SBP) of at least 130 mmHg. The study aims to enroll 11,300 participants. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 11,300 participants. It compares baxdrostat and dapagliflozin to a placebo and dapagliflozin.
What's involved
You will undergo a screening period of up to 14 days. The study will monitor for heart failure events or cardiovascular death for up to 38 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for heart failure events or cardiovascular death for up to 38 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06677060

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

Recruiting
PHASE3Ages 40+InterventionalPrevention
AstraZeneca
~11,300 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:Baxdrostat and dapagliflozinPlacebo and dapagliflozin

At a glance

Recruiting sites
830 of 957 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death
Measured over Event driven; Up to 38 months

Conditions

Heart Failure

Explore related trials

Cardiovascular DisorderHeart FailureHypertensionType 2 Diabetes Mellitus

NCT06677060

Where you'd take part

This study runs at 957 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Birmingham, Alabamano site contact published

    Recruiting

  • Research Site

    Centreville, Alabamano site contact published

    Recruiting

  • Research Site

    Fairhope, Alabamano site contact published

    Recruiting

  • Research Site

    Huntsville, Alabamano site contact published

    Recruiting

  • Research Site

    Mobile, Alabamano site contact published

    Recruiting

  • Research Site

    Sheffield, Alabamano site contact published

    Recruiting

  • Research Site

    Vestavia Hills, Alabamano site contact published

    Recruiting

  • Research Site

    Gilbert, Arizonano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV deathEvent driven; Up to 38 months

    Time to first occurrence of any of the components of the composite of: * Hospitalisation for HF * HF without hospitalisation * CV death