Effect of Dapagliflozin on Myocardial and Renal Function Following Aortic Valve Stenosis Intervention

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, double-blinded, placebo-controlled study in AS patients with subclinical or clinical heart failure undergoing treatment with TAVR.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborator: Aarhus University Hospital
• Treatments: Sodium-Glucose Transporter 2 Inhibitors

Criteria

Inclusion Criteria:

1. Signed informed consent

2. Scheduled TAVR for significant symptomatic AS according to current guidelines

3. Age ≥ 18 years and < 85 years.

4. *

• LVEF ≥ 40% and ≤ 50 % or LVEF ≥ 50% with at least one of the following:

• LV GLS ≤ 15% by TTE

• LV septum or posterior wall thickness ≥ 12mm by TTE or LV mass index ≥108/131 g/m2 for females/males (mild LVH)

• LVEF ≥ 50 % and Nt-proBNP > 600/900 ng/l (sinus rhythm/atrial fibrillation)

5. eGFR > 30 mL/min/1.73 m2

Exclusion Criteria:

1. Medically treated type 1 or type 2 diabetes mellitus

2. Ongoing treatment with an SGLT2-inhibitor or intolerance to SGLT2-inhibitors

3. Life expectancy < 12 months

4. Symptomatic hypotension or persistent SBP < 100 mmHg

5. Contraindications to CMRI

6. HF due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis or hypertrophic obstructive cardiomyopathy

7. Additional other untreated severe valvular disease

8. Liver failure

9. Women who are pregnant or plan to be within the study period.

10. Allergy to any substance in the project medicine, both placebo and active medicine.

11. Previous renal transplantation.

12. Chronic dialysis treatment.