Status:
UNKNOWN
Effect of Dapagliflozin on Myocardial and Renal Function Following Aortic Valve Stenosis Intervention
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
Aortic Stenosis
Left Ventricle Hypertrophied
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
Randomized, double-blinded, placebo-controlled study in AS patients with subclinical or clinical heart failure undergoing treatment with TAVR.
Detailed Description
This is a randomized, double-blinded, placebo-controlled study in AS patients with subclinical or clinical heart failure undergoing treatment with TAVR. It evaluates the effect of Dapagliflozin versus...
Eligibility Criteria
Inclusion
- Signed informed consent
- Scheduled TAVR for significant symptomatic AS according to current guidelines
- Age ≥ 18 years and \< 85 years.
- \*
- 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)
- eGFR \> 30 mL/min/1.73 m2
Exclusion
- Medically treated type 1 or type 2 diabetes mellitus
- Ongoing treatment with an SGLT2-inhibitor or intolerance to SGLT2-inhibitors
- Life expectancy \< 12 months
- Symptomatic hypotension or persistent SBP \< 100 mmHg
- Contraindications to CMRI
- HF due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis or hypertrophic obstructive cardiomyopathy
- Additional other untreated severe valvular disease
- Liver failure
- Women who are pregnant or plan to be within the study period.
- Allergy to any substance in the project medicine, both placebo and active medicine.
- Previous renal transplantation.
- Chronic dialysis treatment.
Key Trial Info
Start Date :
February 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05241431
Start Date
February 12 2022
End Date
April 1 2024
Last Update
February 15 2022
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200