The Role of SGLT2i in Management of Moderate AS
NCT Number: NCT06469645
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Moderate Aortic Valve Stenosis
Interventions: DRUG: Empagliflozin 10 MG
Sponsor: University of East Anglia
Collaborators: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-05-30
Completion Date: 2026-02
Locations: Norfolk and Norwich University Hospital, Norwich, Norfolk, United Kingdom

Summary:
Background:

The aortic valve is like a door in the heart that lets blood flow out to the body. Over time, this valve can get worn out and become too narrow, leading to a condition called aortic stenosis. When this happens, the heart has to work extra hard to push blood through the narrow valve to supply the body with what it needs. This extra effort can cause the heart muscle to become abnormally thick or to have fibrosis. For people with aortic stenosis, this can lead to more problems like feeling out of breath, chest pain, and even needing to go to the hospital. It also increases the risk of dying from heart issues. There is a type of medication called Sodium Glucose Cotransporter 2 (SGLT2) inhibitors, which has been studied in people with weak heart muscle. These medicines were found to help the heart work better and improve the pumping of blood around the body. This can be promising for patients with aortic stenosis because it might make the heart muscle stronger and protect it from damage.

Aim of research study:

The aim of this study is to investigate whether the use of the drug empagliflozin, an SGLT2 inhibitor, prevents the formation of fibrosis or the abnormal thickening of the heart muscle in patients with aortic stenosis. Using advanced imaging techniques (such as echocardiography and cardiovascular magnetic resonance), we intend to study their effect on the heart muscle of patients with aortic stenosis.

Study design:

Patients with moderate aortic stenosis will be invited for participation. Eligible consenting patients will have a baseline assessment with cardiac MRI scan, echocardiography, cardiopulmonary exercise test and validated quality of life questionnaires. They will then be randomised to receive either the SGLT2i for 6 months, or standard of care. All patients will undergo the same tests at 6 months. This way, we aim to investigate the potential changes in the heart muscle and whether the SGLT2 inhibitor prevents fibrosis or hypertrophy.

Primary Outcome Measures: Change in indexed extracellular volume (iECV), The indexed extracellular volume (iECV) (expressed in ml/m2) will be assessed from the Cardiac Magnetic Resonance Scan at baseline and at 6 months follow-up, 6 months
Secondary Outcome Measures: Change in left ventricular ejection fraction, Left ventricular ejection fraction (expressed in percentage, %) will be assessed from the Cardiac Magnetic Resonance Scan at baseline and at 6 months follow-up, 6 months|Change in left ventricular diastolic function as assessed by the E/A ratio, Diastolic function will be assessed from the echocardiographic assessment at baseline and at 6 months follow-up, 6 months|Change in indexed left ventricular mass, Change in indexed left ventricular mass (expressed in g/m2) will be assessed from the Cardiac Magnetic Resonance Scan at baseline and at 6 months follow-up, 6 months|Change in percentage of myocardial uptake of late gadolinium enahncement (LGE), The late gadolinium enhancement will be assessed visually and quantitatively (% of left ventricular mass) from the Cardiac Magnetic Resonance Scan at baseline and at 6 months follow-up, 6 months|Change in cardiac markers (N-terminal pro b-type natriuretic peptide and high sensitivity troponin), Participants will have their cardiac markers (N-terminal pro b-type natriuretic peptide and high sensitivity troponin) tested at baseline and at the 6-month follow-up visit., 6 months|Change in peak oxygen consumption (VO2) as assessed by Cardio-Pulmonary Exercise Test, Participants will undergo a Cardio-pulmonary Exercise Test at baseline and at 6-months follow-up. The peak oxygen consumption will be assessed and changes will be recorded., 6 months|Change in Quality of Life (QoL) as assessed with the Kansas City Cardiomyopathy Questionnaire, Participants will complete the Kansas City Cardiomyopathy Questionnaire at the baseline visit and at the 6-month follow up visit. The score of the Questionnaire scales from 0 to 100, with 0 denoting the worst and 100 the best possible status., 6 months