Clinical trial NCT06804161: SGLT2 INHIBITION for CARDIOVASCULAR ENDPOINT REDUCTION in HYPERTENSION
Official title: SGLT2 INHIBITION for CARDIOVASCULAR ENDPOINT REDUCTION in HYPERTENSION
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atrial Hypertension
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Time until first occurrence of
timeFrame: 7 Years
Secondary outcomes:
Other outcomes:
measure: Safety endpoints
timeFrame: 7 Years
Locations:
Study officials:
affiliation: Universitätsklinikum Schleswig-Holstein - Campus Lübeck
name: Ingo Eitel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: