Project Title

EMPagliflozin after Aortic Valve Replacement. The EMPAVR study - A randomized clinical trial

Background

Patients with severe aortic stenosis (AS) have a morbidity rate of 50% within 2 years, but during the last decades there have been a significant progress in the treatment. Nevertheless there are still about 1/3 of the patients that do not benefit symptomatically. Several explanations could be at stake. Left ventricular (LV) dysfunction secondary to AS is a key part of the underlying pathophysiology and symptoms for patients with this prevalent disease. The fact that about 1/3 of the patients do not experience relief of symptoms after an AVR may in part be explained by delayed or laden LV remodeling. SGLT2 inhibitors are efficacious in heart failure and show great potential for preventing heart failure hospitalizations. SGLT2 inhibitors may also improve LV remodeling and have a role in heart failure with preserved ejection fraction.

Aim

The aim of this study is to test whether SGLT2 inhibition after AVR is superior to placebo in reducing left ventricular mass and improve patient symptoms in patients with AS.

Methods

We have initiated a randomized, placebo-controlled, and double-blind study.

In the project, participants will receive either Empagliflozin or placebo for 6 months. The allocation will be random (randomization), and neither the patient nor the patient's physician will know which treatment is being administered. In the project, patients will be treated according to normal guidelines while simultaneously participating in the project. The participation will last for 6 months. The primary outcome will be change in LV mass indexed to body surface area (measured by CT) from before AVR to 6-months after AVR. We plan to include a total of 206 patients with aortic stenosis in Denmark in the trial, and the randomization will be 1:1.