SGLT2 Inhibition for Cardiovascular Endpoint Reduction in Hypertension

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Schleswig-Holstein AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

10 Dec 2025 → ongoing

Decision date (initial)

2026-05-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA)

External identifiers

EU CT number

2025-520794-39-00

ClinicalTrials.gov

NCT06804161

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess whether the addition of a sodium-glucose co-transporter 2 inhibitor (SGLT2i) to standard antihypertensive treatment confers a reduction in major adverse cardiovascular and renal events.

Conditions and MedDRA coding

Arterial Hypertension

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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) (*excluding patients with myocardial infarction or stroke within preceding 3 months)
4. 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, eGFR ≤60 mL/min/1.73m2 (estimated by CKD-EPICr 2021 formula)

Exclusion criteria 14

1. Known secondary cause of hypertension
2. Myocardial infarction or stroke within the previous 3 months
3. Symptomatic heart failure (including HFrEF, HFmEF, HFpEF)
4. History of Diabetes mellitus
5. History of ketoacidosis
6. Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT] ≥3x the upper limit of normal [ULN])
7. eGFR ≤25 mL/min/1.73 m2 (CKD-EPICr 2021 formula) at Visit 1
8. Receiving therapy with an SGLT2i within 8 weeks prior to randomization or previous intolerance to an SGLT2i
9. Participation in another clinical study with an investigational product during the last month prior to enrolment
10. Known allergy or hypersensitivity to SGLT2i
11. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
12. 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
13. Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma)
14. Inability to give informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 9

1. Time until first occurrence of
2. - non-fatal stroke,
3. - non-fatal myocardial infarction,
4. - revascularisation procedures for atherosclerotic disease,
5. - hospitalisation or emergency department for HF,
6. - unplanned hospitalisation for new-onset atrial fibrillation (AF), new-onset atrial flutter (AFL) or ventricular arrhythmia,
7. - sustained decline in the eGFR of at least 50% (estimated by CKD-EPICr 2021 formula)
8. - end-stage kidney disease o defined as eGFR <15 mL/min/1.73m2 or requiring chronic dialysis or renal transplantation,
9. - death from renal or CV causes

Secondary endpoints 12

1. Individual components of the primary composite outcome
2. All-cause mortality
3. Rate of the decline in the eGFR, estimated by CKD-EPICr 2021 formula at 8 weeks and 48 months
4. Change in systolic BP at 8 weeks, 12 months and 48 months
5. Change in diastolic BP at 8 weeks, 12 months and 48 months
6. Composite of primary endpoint or death from any cause
7. Development of type 2 diabetes,
8. Time to coronary revascularization procedure
9. Improvement in quality of life (respective area-under-the-curve (AUC) of EQ VAS Score and HeartQoL Global Score changes. (Assessment Points: Baseline, 12 months, 24, and 48 months).
10. Decline of cognition (MoCA Test Score, Assessment Points: Baseline, 12 months, 24, and 48 months)
11. Increase of blood markers of neurodegeneration (Ptau 217, Nfl) (Assessment Points: Baseline, 12 months, 24, and 48 months)
12. Frailty (Assessment Points: Baseline, 12 months, 24, and 48 months)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Schleswig-Holstein AöR

Sponsor organisation

Universitaetsklinikum Schleswig-Holstein AöR

Address

Ratzeburger Allee 160

City

Luebeck

Postcode

23538

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Schleswig-Holstein AöR

Contact name

Roza Saraei

Public contact point

Organisation

Universitaetsklinikum Schleswig-Holstein AöR

Contact name

Roza Saraei

Third parties 4

Locations

6 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 34 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications