Using SGLT2 inhibitors to manage moderate aortic valve stenosis
The Role of Sodium Glucose Cotransporter 2 Inhibitors in the Management of Patients With Aortic Stenosis
This study tests if the diabetes medication Empagliflozin can help people with moderate aortic valve stenosis feel better and improve their heart function.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of East Anglia Academic / other |
| Locations | 1 site (Norwich, Norfolk) |
| Trial ID | NCT06469645 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of the SGLT2 inhibitor Empagliflozin on patients with moderate aortic valve stenosis. The study aims to determine if this medication can prevent or slow down adverse changes in the heart muscle and improve patients' exercise tolerance and overall functional capacity. It involves a randomized controlled trial design, focusing on patients who meet specific criteria related to their aortic stenosis severity. The trial will assess both the physiological and quality of life outcomes for participants.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years with moderate aortic stenosis.
Not a fit: Patients with severe aortic stenosis or those requiring cardiac surgery within the next six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve heart function and quality of life for patients with moderate aortic valve stenosis.
How similar studies have performed: While the use of SGLT2 inhibitors has shown promise in heart failure, this specific application in aortic stenosis is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Norwich, Norfolk
- Norfolk and Norwich University Hospital — Norwich, Norfolk, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Vassilios S. Vassiliou, PhD — University of East Anglia
- Study coordinator: Vassilios S. Vassiliou, PhD
- Email: v.vassiliou@uea.ac.uk
- Phone: 01603592534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.