EMPagliflozin After Aortic Valve Replacement
NCT06171802 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 206
Last updated 2026-05-22
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.
Conditions
- Aortic Valve Stenosis
Interventions
- DRUG
-
Empagliflozin
10 mg empagliflozin daily for six months
- DRUG
-
Placebo capsule once daily for six months
Sponsors & Collaborators
-
Rigshospitalet, Denmark
lead OTHER
Principal Investigators
-
Emil L. Fosbøl, MD, PhD · University Hospital of Copenhagen - Rigshospitalet
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-14
- Primary Completion
- 2026-05-08
- Completion
- 2026-05-18
Countries
- Denmark
Study Locations
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