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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Hypertension
• Intervention / Treatment: Drug: SGLT2; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ingo Eitel, Prof. Dr.; Phone Number: 045150044542; Email: cvro@uksh.de
• Study Contact Backup: Name: Elias Rawish, Dr.

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • Universität zu Lübeck
      • Contact: Ingo Eitel, Prof. Dr. med.
      • Contact: Thomas Stiermaier, Dr.med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 1 tablet
Experimental: SGLT2 Arm	Drug: SGLT2; 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time until first occurrence of	7 Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints	AE (general); AE leading to treatment discontinuation; SAE; AE of special interest (AESI): including volume depletion, hypotension, metabolic acidosis and ketoacidosis	7 Years

Collaborators and Investigators

• Sponsor: Prof. Dr. med. Ingo Eitel
• Investigators: Principal Investigator: Ingo Eitel, Prof. Dr., Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): May 30, 2032
• Study Completion (Estimated): May 30, 2032

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 724154

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No