EMPagliflozin after Aortic Valve Replacement - the EMPAVR study

INTERVENTION: Product Name: Glucosemonohydrate with HPMC capsule,Product Code: N/A,Pharmaceutical Form: N/A,Other descriptive name: N/A,Strength: N/A,Pharmaceutical form of the placebo: N/A,Product Name: Jardiance 10 mg film‐coated tablets,Product Code: PRD1594848,Pharmaceutical Form: FILM‐COATED TABLET,Other descriptive name: ,Strength: Empagliflozin 10mg CONDITION: Aortic stenosis ; MedDRA version: 20.1Level: PTClassification code: 10002906Term: Aortic stenosisSystem Organ Class: 100000004866 ; MedDRA version: 20.0Level: PTClassification code: 10002916Term: Aortic valve replacementSystem Organ Class: 100000004865 MedDRA version: 20.0Level: PTClassification code: 10002916Term: Aortic valve replacementSystem Organ Class: 100000004865 MedDRA version: 20.1Level: PTClassification code: 10002906Term: Aortic stenosisSystem Organ Class: 100000004866 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective:The purpose of this trial is to test whether SGLT2 inhibition after AVR is superior to placebo in reducing left ventricular mass and improve patient symptoms. Primary end point(s):Change in left ventricular mass indexed to body surface area (measured by CT) from pre aortic valve replacement (AVR) to 12‐months post‐AVR Secondary Objective: SECONDARY OUTCOME: Secondary end point(s):Composite of death and readmission for any non‐planned cause Secondary end point(s):Left ventricular end‐systolic volume indexed to body surface are (LVESVi measured by CT) Secondary end point(s):Left ventricular global longitudinal strain (LV GLS) (measured by echo) Secondary end point(s):NT‐proBNP change from baseline to 12 months INCLUSION CRITERIA: Severe symptomatic AS AND Surgical or transcatheter AVR within 14 days