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Investigating heart failure treatment with Baxdrostat and 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

PHASE3 · AstraZeneca · NCT06677060

This study is testing if a new combination of two medications can help adults over 40 with heart failure, type 2 diabetes, and heart disease feel better and live longer.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment11300 (estimated)
Ages40 Years and up
SexAll
SponsorAstraZeneca (industry)
Locations928 sites (Birmingham, Alabama and 927 other locations)
Trial IDNCT06677060 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of Baxdrostat in combination with Dapagliflozin in treating heart failure among adults aged 40 and older with type 2 diabetes and established cardiovascular disease. Participants will undergo a pre-screening period to identify eligibility, followed by a screening phase where they will be assessed for inclusion criteria. Those who qualify will receive either the combination treatment or a placebo alongside Dapagliflozin. The study seeks to determine the impact of this treatment on heart failure and cardiovascular death.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 40 and older with type 2 diabetes, established cardiovascular disease, and a history of hypertension.

Not a fit: Patients without a diagnosis of type 2 diabetes or those who do not have established cardiovascular disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with heart failure and reduce cardiovascular mortality.

How similar studies have performed: Other studies have shown promising results with similar combinations of treatments for heart failure, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 927 other locations

+878 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Heart Failure, Heart failure: Baxdrostat, Dapagliflozin, cardiovascular

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.