Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

Eligibility 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 must meet the following criteria at the Screening
• * for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be
• * for participants with screening eGFR \< 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit
• 6. 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
• 1. Previously confirmed diagnosis and treatment of heart failure
• 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