SGLT2 inhibitor to reduce heart-related events in older adults with high blood pressure
Official title: SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension
Run by University of Luebeck · NCT06804161 · Data updated 2026-11-12
This study will test whether an SGLT2 inhibitor can reduce heart-related events in people aged 60 and older with high blood pressure and a history of or risk factors for cardiovascular disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | University of Luebeck Academic / other |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | May 30, 2032 |
| Study ends | May 30, 2032 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT06804161 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 60 or older with systolic BP >140 mmHg or diastolic BP >90 mmHg who have a history of cardiovascular disease or major cardiovascular risk factors and do not have diabetes, symptomatic heart failure, recent MI/stroke, or secondary hypertension.
✕Probably not a fit
People with diabetes, symptomatic heart failure, a recent myocardial infarction or stroke within three months, or a known secondary cause of hypertension are excluded and would not benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 interventional trial enrolls people aged 60 or older who have hypertension and either prior cardiovascular events or major cardiovascular risk factors. Participants are assigned to receive an SGLT2 inhibitor or placebo in addition to usual care and are followed for cardiovascular outcomes and end-organ damage. Key exclusions include diabetes, symptomatic heart failure, recent myocardial infarction or stroke, and known secondary causes of hypertension. The goal is to determine whether SGLT2 inhibition can lower blood pressure-related complications beyond current therapies.
Why it matters
Potential benefit: If successful, the treatment could lower blood pressure-related complications and reduce heart attacks, strokes, and other cardiovascular events in older people with hypertension.
How similar studies have gone: SGLT2 inhibitors have demonstrated cardiovascular and heart-failure benefits in people with type 2 diabetes and in heart-failure populations, but their benefit specifically for primary hypertension without diabetes remains unproven.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany Recruiting
Study contacts
- Principal investigator: Ingo Eitel, Prof. Dr. — Universitätsklinikum Schleswig-Holstein - Campus Lübeck
- Study coordinator: Ingo Eitel, Prof. Dr.
- Email: cvro@uksh.de
- Phone: 045150044542
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.