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Taking people in ChinaPhase 3

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.

Key facts

Who runs it
AstraZeneca
Where
Baotou, Beijing, Changchun, Changde, Changsha, Changzhou, Chengdu, Chifeng, Chongqing, Guangzhou, Harbin, Hefei, Hengyang, Heze, Huangshi, Huizhou, Jinan, Jining, Kaifeng, Liaocheng, Linyi, Lishui, Luoyang, Meihekou, Nanchang, Nanjing, Nantong, Nanyang, Panjin, Pingxiang, Sanya, Shanghai, Shenyang, Siping, Suzhou, Taiyuan, Taizhou, Tianjin, Wenzhou, Wuhan, Xi'an, Xianyang, Xuzhou, Yinchuan, Zhumadian, and Zigong, ChinaSee the 46 sitesAlso in 34 other countries, 775 sites
Registry title
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Status
Recruiting
Phase
Phase 3
People taking part
11,300 people, planned
Started
14 Mar 2025
Expected to end
17 Dec 2029
Type of study
Interventional, 2 groups
Treatments tested
  • Baxdrostat and dapagliflozin
  • Placebo and dapagliflozin
Record updated
21 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in China

Also in 34 other countries, 775 sites

  • BaotouHospital not named in the registryTaking people
  • BeijingHospital not named in the registryNo longer taking part
  • ChangchunHospital not named in the registryTaking people
  • ChangdeHospital not named in the registryTaking people
  • ChangshaHospital not named in the registryTaking people
  • ChangzhouHospital not named in the registryTaking people
  • ChengduHospital not named in the registryTaking people
  • ChifengHospital not named in the registryTaking people
  • ChongqingHospital not named in the registryTaking people
  • GuangzhouHospital not named in the registryTaking people
  • HarbinHospital not named in the registryTaking people
  • HefeiHospital not named in the registryNo longer taking part
  • HengyangHospital not named in the registryTaking people
  • HezeHospital not named in the registryTaking people
  • HuangshiHospital not named in the registryTaking people
  • HuizhouHospital not named in the registryTaking people
  • JinanHospital not named in the registryTaking people
  • JiningHospital not named in the registryTaking people
  • KaifengHospital not named in the registryTaking people
  • LiaochengHospital not named in the registryTaking people
  • LinyiHospital not named in the registryTaking people
  • LishuiHospital not named in the registryTaking people
  • LuoyangHospital not named in the registryTaking people
  • MeihekouHospital not named in the registryTaking people
  • NanchangHospital not named in the registryTaking people
  • NanjingHospital not named in the registryTaking people
  • NantongHospital not named in the registryTaking people
  • NanyangHospital not named in the registryTaking people
  • PanjinHospital not named in the registryTaking people
  • PingxiangHospital not named in the registryTaking people
  • SanyaHospital not named in the registryTaking people
  • ShanghaiHospital not named in the registryTaking people
  • ShenyangHospital not named in the registryTaking people
  • SipingHospital not named in the registryTaking people
  • SuzhouHospital not named in the registryTaking people
  • TaiyuanHospital not named in the registryTaking people
  • TaizhouHospital not named in the registryTaking people
  • TianjinHospital not named in the registryTaking people
  • WenzhouHospital not named in the registryTaking people
  • WuhanHospital not named in the registryTaking people
  • Xi'anHospital not named in the registryTaking people
  • XianyangHospital not named in the registryTaking people
  • XuzhouHospital not named in the registryTaking people
  • Yinchuan, ChinaHospital not named in the registryTaking people
  • ZhumadianHospital not named in the registryTaking people
  • ZigongHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

  • Baxdrostat/DapagliflozinTreatment being tested

    Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.

    Treatment: Baxdrostat and dapagliflozin

  • Placebo/DapagliflozinTreatment being tested

    Patients will receive a dose of dapagliflozin in combination with matching placebo

    Treatment: Placebo and dapagliflozin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests baxdrostat with dapagliflozin to prevent heart failure in people with diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 October 2026