A Randomized Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation in Patients After Renal Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Safety and efficacy of renal denervation in patients after renal transplantation
研究概览
简要总结
The study is aiming to document the safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. Catheter-based renal denervation will be performed using CE marked, percutaneous Symplicity catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient after renal transplantation (> 6 month) without resection of native kidneys
- •systolic blood pressure >=150 mmHg
- •on 3 or more antihypertensive medications
- •Individual is 18 years of age
- •Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
排除标准
- •secondary causes and a white coat hypertension
- •renal artery abnormalities
- •eGFR < 30mL/min (MDRD)
- •severe Aortic valve stenosis
- •Individual is pregnant, nursing or planning to be pregnant
结局指标
主要结局
Safety and efficacy of renal denervation in patients after renal transplantation
时间窗: Baseline to 6 months
Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events. Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
次要结局
- Effect of renal denervation in patients after renal transplantation on different organ systems.(Baseline to 6 month)
研究者
Simon Schneider
Simon Schneider, MD; 1.Medizinische Klinik und Poliklinik, Klinikum rechts der Isar
Technical University of Munich