Effect of Dapagliflozin on myocardial and renal function following aortic valve stenosis interventio
- Conditions
- Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Aortic stenosis
- Registration Number
- CTIS2024-514868-11-00
- Lead Sponsor
- Aarhus Universitetshospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 106
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% 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
1. Medically treated type 1 or type 2 diabetes mellitus, 10. Allergy to any substance in the project medicine, both placebo and active medicine., 11. Previous renal transplantation., 12. Chronic dialysis treatment., 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.**
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method