At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Baxdrostat and dapagliflozin (drug), Placebo and dapagliflozin (other)
- How long the study runs
- Study runs about 57 months (dates as stated)
- About the drug or intervention
- Baxdrostat and dapagliflozin — drug: baxdrostat tablet and dapagliflozin tablet · Placebo and dapagliflozin — other: placebo tablet and dapagliflozin tablet
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 40 Years and over
- Who
- All
- Number of participants
- 11,300
- Started
- 2025-03-14
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure
- • Phase3 - 11,300 participants
- • 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
Who can take part?
- • Ages 40 Years and over
- • Diagnosed with heart failure
Where?
- • Aberdeen - Research Site
- • Chesterfield - Research Site
- • Dundee - Research Site
- • Gatley - Research Site
- • +14 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participants of any sex and gender must be ≥ 40 years old at the time of signing the agreement to take part.
- ✓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:
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (18 UK sites)
Research Site
Aberdeen AB25 2ZN, United Kingdom
Research Site
Chesterfield S40 4AA, United Kingdom
Research Site
Dundee DD1 9SY, United Kingdom
Research Site
Gatley SK8 4NQ, United Kingdom
Research Site
Glasgow G31 2ER, United Kingdom
Research Site
Glasgow G51 4TF, United Kingdom
Research Site
London E11BB, United Kingdom
Research Site
Norwich NR128DU, United Kingdom
Research Site
Penzance TR18 3DX, United Kingdom
Research Site
Redruth TR16 4ET, United Kingdom
Research Site
Sandbach CW11 1EQ, United Kingdom
Research Site
Southampton SO303JB, United Kingdom
Research Site
Stockton-on-Tees TS19 8PE, United Kingdom
Research Site
Swansea SA6 6NL, United Kingdom
Research Site
Weston-super-Mare BS24 7PR, United Kingdom
Research Site
Wolverhampton WV10 0QP, United Kingdom
Research Site
Woodbridge IP136TH, United Kingdom
Research Site
Yate BS37 4AX, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT