Actively Recruiting
SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension
Led by Prof. Dr. med. Ingo Eitel · Updated on 2025-12-22
3000
Participants Needed
1
Research Sites
337 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hypertension (HTN) is a leading cause of cardiovascular disease (CVD). Despite existing therapies, patients with HTN still face substantial risks, due to pre-existing and ongoing end-organ damage due, in part, to inadequate blood pressure (BP) control. SGLT2 inhibitors (SGLT2i) are recommended for both type-2 diabetes and heart failure to reduce morbidity and mortality. SGLT2i reduce BP and might also improve outcomes for HTN by reducing end-organ damage through diverse other actions. However, confirmation that SGLT2i are clinically useful for the management of HTN is required to change guidelines and clinical practice.
CONDITIONS
Official Title
SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg measured twice on different days for new hypertension, or once at screening for existing hypertension
- History of at least one cardiovascular event such as myocardial infarction or stroke (excluding those within the past 3 months), stable angina, coronary heart disease, peripheral arterial disease, or transient ischemic attack
- Or presence of at least one cardiovascular risk factor: current smoking of more than one cigarette daily for at least one year, LDL cholesterol over 4.0 mmol/l, age 75 years or older, ESC HeartScore above 15%, or body mass index over 32 kg/m2
You will not qualify if you...
- Known secondary cause of hypertension
- Myocardial infarction or stroke within the previous 3 months
- Symptomatic heart failure, including reduced, mid-range, or preserved ejection fraction
- History of diabetes mellitus
- History of ketoacidosis
- Liver impairment with enzymes greater than three times the upper limit of normal
- Estimated glomerular filtration rate under 25 mL/min/1.73 m2
- Treatment with an SGLT2 inhibitor within 8 weeks before the study or previous intolerance to SGLT2 inhibitors
- Participation in another clinical trial with an investigational product within the last month
- Known allergy to SGLT2 inhibitors
- Women who are pregnant, nursing, or planning pregnancy during the study
- Any medical condition outside kidney and cardiovascular disease with life expectancy under 2 years
- Active cancer needing treatment, except successfully treated basal or squamous cell carcinoma
- Unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
Research Team
I
Ingo Eitel, Prof. Dr.
CONTACT
E
Elias Rawish, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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