SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorProf. Dr. med. Ingo Eitel

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SGLT2
  • Placebo

Treatment groups

3,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Prof. Dr. med. Ingo Eitel

Lead sponsor

University of Luebeck

Sponsor institution