Health TrialsbyHealthPanel

SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension

ConditionAtrial 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

This trial does not accept healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

  • SGLT2

    Drug

    10 mg

  • Placebo

    Drug

    1 tablet

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: SGLT2 ArmExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time until first occurrence of

Time frame
7 Years

Secondary outcomes

Other outcomes

1

Safety endpoints

* AE (general) * AE leading to treatment discontinuation * SAE * AE of special interest (AESI): including volume depletion, hypotension, metabolic acidosis and ketoacidosis

Time frame
7 Years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prof. Dr. med. Ingo Eitel

Lead sponsor

University of Luebeck

Sponsor institution

Source ClinicalTrials.gov
Apply now