EMPagliflozin After Aortic Valve Replacement - the EMPAVR Study - a Randomized Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 empagliflozin (SGLT2i) or placebo to investigate whether empagliflozin is superior to placebo in reducing left ventricular mass and improve symptoms to 6 months.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Severe symptomatic aortic stenosis AND Surgical or transcatheter aortic valve replacement within 14 days
Locations
Other Locations
Denmark
University Hospital of Copenhagen, Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Louise M. Sørensen, MD
louise.marqvard.soerensen.02@regionh.dk
004535459520
Time Frame
Start Date: 2024-02-14
Estimated Completion Date: 2026-01
Participants
Target number of participants: 205
Treatments
Active_comparator: Empagliflozin
Empagliflozin 1 capsule of 10 mg, once daily for six months.
Placebo_comparator: Placebo
1 capsule of placebo, once daily for six months
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark