CTIS2024-514868-11-00
Active, Not Recruiting
Phase 1
Effect of Dapagliflozin on myocardial and renal function following aortic valve stenosis intervention
Aarhus Universitetshospital0 sites106 target enrollmentJune 13, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Aortic stenosis
- Sponsor
- Aarhus Universitetshospital
- Enrollment
- 106
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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% 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, 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.\*\*
Outcomes
Primary Outcomes
Not specified
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