SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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)

⁃ 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

Locations
Other Locations
Germany
Universität zu Lübeck
RECRUITING
Lübeck
Contact Information
Primary
Ingo Eitel, Prof. Dr.
cvro@uksh.de
045150044542
Backup
Elias Rawish, Dr.
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2032-05-30
Participants
Target number of participants: 3000
Treatments
Experimental: SGLT2 Arm
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Prof. Dr. med. Ingo Eitel

This content was sourced from clinicaltrials.gov