Safety of low dose ACE inhibition in living kidney donors.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To evaluate safety of low dose ACEi (Ramipril 1.25mg) in living kidney donors.
研究概览
简要总结
In this open label, randomised clinical trial, we propose to explore the safety of low dose ACE inhibitor ie. Ramipril 1.25mg in renal donors post donation and their possible effects on arterial stiffness and measured GFR. We will measure GFR, aortic stiffness and FMD in donors, pre donation and post donation. After informed consent (as in Annexure 3), all clinical investigations will be recorded and within 14 days post nephrectomy, measured GFR, PVW and FMD will be assessed. Subjects will be randomised into two groups with one receiving low dose Ramipril 1.25mg while other group serving s control with no medication. Subjects shall be reassessed after 6 months for any adverse effects and changes in measured GFR using Iohexol clearance, arterial stiffness using PWV and FMD. If a significant benefit of ACE inhibitor is documented on reducing aortic stiffness which is a surrogate marker of cardiovascular risk, than it will be worthwhile to prescribe ACE inhibitors routinely to all post renal donation patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •age 18 to 60 years.
排除标准
- •diagnosis of hypertension 2) history of allergy to ACE inhibitors 3) History of angioedema 4) history of allergy to iodinated contrast media 5) systolic BP < 100mm Hg 6)Planning pregnancy in next 9 months after renal donation (females).
结局指标
主要结局
To evaluate safety of low dose ACEi (Ramipril 1.25mg) in living kidney donors.
时间窗: 6 months
次要结局
- To ascertain change in measured GFR in living donors at 6 months after kidney donation by plasma clearance of Iohexol(6 months)
- To ascertain change in vascular stiffness in living donors at 6 months after kidney donation by PWV(6 months)