The Role of SGLT2i in Management of Moderate AS

Launched by UNIVERSITY OF EAST ANGLIA · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called empagliflozin, which belongs to a group of drugs known as SGLT2 inhibitors, on patients with moderate aortic valve stenosis. Aortic stenosis is a condition where the aortic valve, which helps blood flow from the heart to the body, becomes narrow and makes the heart work harder. The goal of the study is to see if empagliflozin can prevent the thickening of the heart muscle or reduce damage to it, which can cause symptoms like breathlessness and chest pain.

To participate in this trial, you must be over 18 years old and diagnosed with moderate aortic stenosis. If you join, you will undergo a series of tests, including heart scans, to assess your condition at the beginning and after six months of treatment. You will either receive empagliflozin or the usual care for your condition. The study aims to determine if this medication can improve heart health for people with aortic stenosis. It's important to know that certain health conditions and treatments may exclude you from participating, so discussing your eligibility with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• 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