The effect of treatment with Dapagliflozin on heart and kidney function after catheter based aortic valve replacement for aortic stenosis

Phase 1

Conditions: Patients with aortic stenosis undergoing trans catheter aortic valve replacement.
MedDRA version: 20.0Level: LLTClassification code 10058186Term: Aortic valve stenosis and insufficiencySystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2021-004271-14-DK

Lead Sponsor: Aarhus University Hospital, department of Cardiology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 104

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 LV GLS - LV septum or posterior wall thickness >/= 12mm by echo 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

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.