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

Participants include men and women 40 years of age or more 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, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol. - BaxDuo Prevent HF

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240738

Enrollment

11300

Registered

2025-03-18

Start date

2025-03-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Interventions

Baxdrostat/Dapagliflozin arm: One tablet of baxdrostat and one tablet of dapagliflozin once daily Placebo/Dapagliflozin arm: One matching placebo tablet and one tablet of dapagliflozin once daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants of any sex and gender must be 40 years old or more at the time of signing the informed consent. 2. Diagnosed with T2DM and requiring treatment 3. Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease) 4. History of HTN and an SBP 130 mmHg(either the most recent value within 4 weeks of screening or at the Screening Visit) or more at screening and 120 mmHg or less at the Randomisation Visit. 5. Serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR: _for participants with screening eGFR 45 mL/min/1.73 m2 or more, potassium must be 3.0 or more and 4.8 mmol/L or less at the Screening Visit _ for participants with screening eGFR 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

Exclusion criteria

Exclusion criteria: 1. Previously confirmed diagnosis and treatment of chronic symptomatic heart failure 2. An eGFR 10.5% (> 91 mmol/mol) at screening 5. Serum sodium < 135 mmol/L at screening, determined as per central laboratory assessment 6. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation 7. Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation 8. Percutaneous coronary intervention or Transcatheter Aortic Valve Replacement within 1 month prior to randomisation 9. Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history 10. Documented history of adrenal insufficiency 11. Any dialysis (including for acute kidney injury) within 3 months prior to screening 12. Any acute kidney injury within 3 months prior to screening 13. History or known allergy/hypersensitivity to the study treatment, as judged by the Investigator (eg, SGLT2i or active substance or excipients)

Design outcomes

Primary

Measure	Time frame
- To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death [Time Frame: Event 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	—

Countries

Argentina, Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey

Contacts

Public ContactYuji Ageishi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026