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SGLT2 INHIBITION FOR CARDIOVASCULAR ENDPOINT REDUCTION IN HYPERTENSION

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520794-39-00
Acronym
724154
Enrollment
3112
Registered
2025-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension

Brief summary

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

Detailed description

Individual components of the primary composite outcome, All-cause mortality, Rate of the decline in the eGFR, estimated by CKD-EPICr 2021 formula at 8 weeks and 48 months, Change in systolic BP at 8 weeks, 12 months and 48 months, Change in diastolic BP at 8 weeks, 12 months and 48 months, Composite of primary endpoint or death from any cause, Development of type 2 diabetes,, Time to coronary revascularization procedure, 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)., Decline of cognition (MoCA Test Score, Assessment Points: Baseline, 12 months, 24, and 48 months), Increase of blood markers of neurodegeneration (Ptau 217, Nfl) (Assessment Points: Baseline, 12 months, 24, and 48 months), Frailty (Assessment Points: Baseline, 12 months, 24, and 48 months)

Interventions

Sponsors

Universitaetsklinikum Schleswig-Holstein AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
Individual components of the primary composite outcome, All-cause mortality, Rate of the decline in the eGFR, estimated by CKD-EPICr 2021 formula at 8 weeks and 48 months, Change in systolic BP at 8 weeks, 12 months and 48 months, Change in diastolic BP at 8 weeks, 12 months and 48 months, Composite of primary endpoint or death from any cause, Development of type 2 diabetes,, Time to coronary revascularization procedure, 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)., Decline of cognition (MoCA Test Score, Assessment Points: Baseline, 12 months, 24, and 48 months), Increase of blood markers of neurodegeneration (Ptau 217, Nfl) (Assessment Points: Baseline, 12 months, 24, and 48 months), Frailty (Assessment Points: Baseline, 12 months, 24, and 48 months)

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026