EMPagliflozin After Aortic Valve Replacement - The EMPAVR Study - A Randomized Clinical Trial

2023-504731-40-01

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.

2024-02-14

2025-08-01

2026-01-01

Recruiting

Early phase I

205

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo-controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double-blinded trial', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 205, 'type': 'ESTIMATED'}}

2024-04-11