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EMPagliflozin after Aortic Valve Replacement - the EMPAVR study - a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504731-40-01
Acronym
2023-504731-40-00
Enrollment
206
Registered
2023-11-08
Start date
2024-02-07
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Aortic stenosis

Brief summary

Change in left ventricular mass indexed to body surface area (measured by CT) from pre aortic valve replacement (AVR) to 12-months post-AVR

Detailed description

Left ventricular end-systolic volume indexed to body surface are (LVESVi measured by CT), Left ventricular global longitudinal strain (LV GLS) (measured by echo), NT-proBNP change from baseline to 12 months, Composite of death and readmission for any non-planned cause

Interventions

DRUGGlucosemonohydrate with HPMC capsule
DRUGJardiance 10 mg film-coated tablets

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in left ventricular mass indexed to body surface area (measured by CT) from pre aortic valve replacement (AVR) to 12-months post-AVR

Secondary

MeasureTime frame
Left ventricular end-systolic volume indexed to body surface are (LVESVi measured by CT), Left ventricular global longitudinal strain (LV GLS) (measured by echo), NT-proBNP change from baseline to 12 months, Composite of death and readmission for any non-planned cause

Countries

Denmark

Outcome results

None listed

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