Phase III Study Investigating Heart Failure and Cardiovascular Death with Baxdrostat in combination with Dapagliflozin - Prevent-HF

Study identifier:D6973C00001

ClinicalTrials.gov identifier:NCT06677060

EudraCT identifier:N/A

CTIS identifier:2024-514506-32-00

Will Be Recruiting

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

Medical condition

heart failure

Phase

Phase 3

Healthy volunteers

Study drug

Baxdrostat and dapagliflozin

Sex

All

Estimated Enrollment

11300

Study type

Interventional

Age

40 Years - n/a

Date

Study Start Date: 28 Mar 2025

Estimated Primary Completion Date: 17 Dec 2029

Estimated Study Completion Date: 17 Dec 2029

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Participants of any sex and gender must be ≥ 40 years old 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 at screening and ≥ 120 mmHg at the Randomisation Visit.
5. Central laboratory serum potassium ≥ 3.0 to ≤ 4.8 mmol/L at screening
6. At least one additional risk factor for HF:
o Age ≥ 70 years
o UACR > 20 mg/g
o eGFR < 60 mL/min/1.73 m2
o History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)
o History of atrial fibrillation or atrial flutter
o NT-proBNP > 125 ng/L

Exclusion Criteria

1. Established heart failure diagnosis
2. An eGFR < 30 mL/min/1.73 m2 at screening
3. Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening
4. Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c > 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 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)
14. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant)
15. Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to screening)
16. Drug or alcohol abuse that in the Investigator’s judgement makes the participant a poor candidate for the study
17. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone) or aldosterone synthase inhibitor within 4 weeks prior to screening and/or during the study
18. Concomitant therapy with strong inducers of cytochrome P450
19. Use of potassium-sparing diuretics (such as triamterene or amiloride) and direct renin inhibitor (eg, aliskiren) at the time of screening
20. Use of potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening

No locations available

Arms	Assigned Interventions
Experimental: Baxdrostat/Dapagliflozin 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.	Drug: Baxdrostat and dapagliflozin baxdrostat tablet and dapagliflozin tablet Other Name: Baxdrostat CIN-107
Experimental: Placebo/Dapagliflozin Patients will receive a dose of dapagliflozin in combination with matching placebo	Other: Placebo and dapagliflozin placebo tablet and dapagliflozin tablet

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]