SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension (SGLT2-HYPE)

Prof. Dr. med. Ingo Eitel

Status and phase: Enrolling; Phase 3

Conditions: Atrial Hypertension

Treatments: Drug: Placebo; Drug: SGLT2

Study type: Interventional

Funder types: Other

Identifiers

NCT06804161

724154

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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3,000 participants in 2 patient groups, including a placebo group

SGLT2 Arm

Experimental group

Treatment:

Drug: SGLT2

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo