The Role of Sodium Glucose Cotransporter 2 Inhibitors in the Management of Patients With Aortic Stenosis

R212199

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.

2024-05-30

2026-02-01

2026-02-01

Recruiting

Early phase I

104

Inclusion Criteria: 1. Moderate aortic stenosis (aortic valve peak velocity ≥ 3m/s or mean gradient 20-40mmHg, or Aortic valve area 1.0-1.5cm2) 2. Age over 18 years Exclusion Criteria: 1. Severe aortic stenosis (aortic valve peak velocity ≥ 4m/s or mean \> 40mmHg or Aortic valve area \< 1.0cm2) or planned cardiac surgery or likely need for surgery within 6 months. 2. Previous valve replacement 3. Severe hypertension (systolic \>180mmHg or diastolic \>100mmHg) 4. Acute pulmonary oedema or cardiogenic shock 5. Coexisting other valvular lesion of more than moderate severit. 6. Coexisting hypertrophic cardiomyopathy or amyloidosis with cardiac involvement 7. Any contraindications to MRI scanning including eGFR \<30ml/min/1.73m2 8. Pregnancy or breast-feeding 9. Concomitant SGLT2 inhibitor therapy 10. Inability to receive SGLT2 inhibitor therapy 11. History of diabetes type 1 or 2 12. Severe peripheral vascular disease or non-healed leg ulcers 13. Severe liver disease 14. Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel-group prospective randomised open-label blinded endpoint (PROBE) controlled trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 104, 'type': 'ESTIMATED'}}

2024-06-21