SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension

NCT06804161 | Recruiting Phase 3 DMC

• 1 other identifier: 724154
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Hypertension

Outcome Measures

Primary Outcomes (1)

• Time until first occurrence of

  7 Years

Other Outcomes (1)

• Safety endpoints

  7 Years

Study Arms (2)

SGLT2 Arm

EXPERIMENTAL

Drug: SGLT2

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SGLT2 DRUG

10 mg

SGLT2 Arm

Placebo DRUG

1 tablet

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. med. Ingo Eitel: lead

Study Sites (1)

Universität zu Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Study Officials

• Ingo Eitel, Prof. Dr.

  Universitätsklinikum Schleswig-Holstein - Campus Lübeck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingo Eitel, Prof. Dr.

CONTACT

045150044542; cvro@uksh.de

Elias Rawish, Dr.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of department of medical clinic II

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 3, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): May 30, 2032
• Study Completion (Estimated): May 30, 2032
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

DE (1)