Phase 3 study for people with Heart Disease

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

• 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 Criteria:

• 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
• 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
• Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
• Documented history of adrenal insufficiency
• 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