Status:
ACTIVE_NOT_RECRUITING
EMPagliflozin After Aortic Valve Replacement
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is a randomized, placebo-controlled, and double-blinded trial in patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR). After AVR, patients will be randomized 1:1 to e...
Detailed Description
In this randomized, placebo-controlled, and double-blinded trial we investigate whether empagliflozin (SGLT2i) is superior to placebo in reducing left ventricular mass and improve symptoms. All patie...
Eligibility Criteria
Inclusion
- Severe symptomatic aortic stenosis AND Surgical or transcatheter aortic valve replacement within 14 days
Exclusion
- Prior treatment with a SGLT2i
- Left ventricular ejection fraction \< 45%
- Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min
- Hypersensitivity to empagliflozin or placebo tablet
- Type I Diabetes
- Patients who do not understand Danish or English
- Women who are pregnant or are nursing or plan to become pregnant during trial
Key Trial Info
Start Date :
February 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT06171802
Start Date
February 14 2024
End Date
June 1 2026
Last Update
November 20 2025
Active Locations (1)
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1
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, Denmark, 2100