Effect of Dapagliflozin on myocardial and renal function following aortic valve stenosis intervention - DAPAS

Aarhus University Hospital, department of Cardiology0 个研究点目标入组 104 人开始时间: 2021年10月20日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•1. Signed informed consent
•2. Scheduled TAVR for significant symptomatic AS according to current guidelines
•3. Age > 18 years and < 85 years.
•- 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

•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.

发起方

Aarhus University Hospital, department of Cardiology