CTIS2024-514868-11-00进行中（未招募）1 期
Effect of Dapagliflozin on myocardial and renal function following aortic valve stenosis intervention
Aarhus Universitetshospital0 个研究点目标入组 106 人开始时间: 2024年6月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.**
研究者
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