Active — Not RecruitingPhase 4

EMPagliflozin After Aortic Valve Replacement

Denmark205 participantsStarted 2024-02-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in left ventricular mass indexed to body surface area

Timeframe: 6 months from discharge post-Aortic Valve Replacement

Trial details

NCT IDNCT06171802

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Aortic Valve Stenosis trials