SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension

Prior treatment

• Myocardial infarction or stroke within the previous 3 months
• Receiving therapy with an SGLT2i within 8 weeks prior to randomization or previous intolerance to an SGLT2i
• Participation in another clinical study with an investigational product during the last month prior to enrolment

Other illness

• Symptomatic heart failure (including HFrEF, HFmEF, HFpEF)
• History of Diabetes mellitus
• History of ketoacidosis
• Known allergy or hypersensitivity to SGLT2i
• Any medical condition - outside the renal and CV disease area - with a life expectancy of less than 2 years based on investigator's clinical judgement
• Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)

Lab values

• Hepatic impairment (aspartate transaminase \[AST\] or alanine transaminase \[ALT\] \>3x the upper limit of normal \[ULN\])
• eGFR \<25 mL/min/1.73 m2 (CKD-EPICr 2021 formula) at Visit 1

Other

• Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• Inability to give informed consent

• Age ≥60 years
• Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg in two measurements on different days for newly diagnosed hypertension, or through one measurement at the screening visit for patients with an existing diagnosis of hypertension.
• A history of at least one CV event (myocardial infarction\* or stroke\*; stable angina or clinical evidence of coronary heart disease; peripheral arterial disease; transient ischemic attack)
  • or
  • The presence of at least one cardiovascular risk factor (current smoking of more than one cigarette per day during at least 1 year; LDL-cholesterol \> 4,0 mmol/l, Age ≥ 75 years, ESC HeartScore \> 15%, BMI \> 32 kg/m2)
  • \*excluding patients with myocardial infarction or stroke within preceding 3 months