BridgeMD
SGLT2 INHIBITION FOR CARDIOVASCULAR ENDPOINT REDUCTION IN HYPERTENSION
EU CTIS ID: 2025-520794-39-00
What this study is testing
To assess whether the addition of a sodium-glucose co-transporter 2 inhibitor (SGLT2i) to standard antihypertensive treatment confers a reduction in major adverse cardiovascular and renal events.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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) (*excluding patients with myocardial infarction or stroke within preceding 3 months)
- 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, eGFR ≤60 mL/min/1.73m2 (estimated by CKD-EPICr 2021 formula)
You likely can't join if
- Known secondary cause of hypertension
- 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
See the full eligibility criteria
- 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) (*excluding patients with myocardial infarction or stroke within preceding 3 months)
- 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, eGFR ≤60 mL/min/1.73m2 (estimated by CKD-EPICr 2021 formula)
- Known secondary cause of hypertension
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ukraine. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.