EMPagliflozin After Aortic Valve Replacement

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

Severe symptomatic aortic stenosis AND Surgical or transcatheter aortic valve replacement within 14 days

Exclusion Criteria:

• 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