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SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension

NCT ID: NCT06804161

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2032-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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SGLT2 Arm

Group Type EXPERIMENTAL

SGLT2

Intervention Type DRUG

10 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet

Interventions

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SGLT2

10 mg

Intervention Type DRUG

Placebo

1 tablet

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. med. Ingo Eitel

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Ingo Eitel

Head of department of medical clinic II

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ingo Eitel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Locations

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Universität zu Lübeck

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ingo Eitel, Prof. Dr.

Role: CONTACT

Phone: 045150044542

Email: [email protected]

Elias Rawish, Dr.

Role: CONTACT

Facility Contacts

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Ingo Eitel, Prof. Dr. med.

Role: primary

Thomas Stiermaier, Dr.med

Role: backup

Other Identifiers

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724154

Identifier Type: -

Identifier Source: org_study_id