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Clinical Trials in Germany / NCT06804161
Recruiting Phase 3

SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension

NCT06804161 · tracked via the Priya Life Science Germany tracker
Sponsor
Prof. Dr. med. Ingo Eitel
Phase
Phase 3
Started
2025-12-10
Last updated
2025-12-22

Condition(s) studied

Atrial Hypertension

Investigational drug(s) / intervention(s)

SGLT2Placebo

SGLT2: 10 mg

Placebo: 1 tablet

Study summary

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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Universität zu Lübeck Lübeck Schleswig-Holstein Recruiting

More Prof. Dr. med. Ingo Eitel trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06804161 on ClinicalTrials.gov ↗ ← All trials in Germany