Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT06804161
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥60 years
2. 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.
3. 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
Exclusion Criteria:- Known secondary cause of hypertension
* Myocardial infarction or stroke within the previous 3 months
* Symptomatic heart failure (including HFrEF, HFmEF, HFpEF)
* History of Diabetes mellitus
* History of ketoacidosis
* 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
* 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
* Known allergy or hypersensitivity to SGLT2i
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* 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)
* Inability to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT06804161
Study Brief:
Protocol Section:
NCT06804161