Tests baxdrostat with dapagliflozin to prevent heart failure in people with diabetes
Tests baxdrostat added to dapagliflozin in adults with type 2 diabetes and heart disease.
Plain-language title generated from the registry record
Registry title: Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Key facts
- Where
- Bellavista, Callao, Chorrillos, Cusco, Lima, and Piura, PeruSee the 6 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older with type 2 diabetes, heart or blood vessel disease, and high blood pressure, who do not yet have heart failure but have extra risk factors for it.
- Age
- 40 years or older
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes needing treatment, established heart or blood vessel disease (ischaemic heart disease, cerebrovascular disease or peripheral arterial disease), history of high blood pressure with SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at randomisation, and at least one more risk factor for heart failure (age ≥ 70 years, UACR > 20 mg/g, eGFR < 60 mL/min/1.73 m2, polyvascular disease, atrial fibrillation or flutter, or NT-proBNP > 125 ng/L).
- Earlier treatment
- People not taking an SGLT2 inhibitor, or taking one for less than 4 weeks, first take dapagliflozin 10 mg once daily for at least 4 weeks (not more than 6 weeks) before randomisation.
- Biomarker or test result
- Serum potassium must be within the level set by the study. Blood pressure, UACR, eGFR and NT-proBNP values are listed under disease stage.
Main reasons for not taking part
- Heart failure already diagnosed and treated
- eGFR < 30 mL/min/1.73 m2 at screening
- Known high potassium (≥ 5.5 mmol/L) within 3 months before screening
- Type 1 diabetes, or uncontrolled type 2 diabetes with HbA1c > 10.5% (91 mmol/mol)
- Dialysis or acute kidney injury within 3 months before screening
Read by machine on 10 November 2026.
Where in Peru
- BellavistaHospital not named in the registryTaking people
- CallaoHospital not named in the registryTaking people
- ChorrillosHospital not named in the registryTaking people
- CuscoHospital not named in the registryNot yet recruiting
- LimaHospital not named in the registryTaking people
- PiuraHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06677060EU 2024-514506-32-00
- Record updated
- 21 October 2026
- Original description
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, and with at least one additional risk factor for HF.Read full original descriptionShow less
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 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.
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; 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; 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; Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history; Documented history of adrenal insufficiency; 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.