Effect of Catheter-based Radiofrequency Ablation Therapy of the Renal Sympathetic-Nerve System for Patient With Sleep Apnea Syndrome and Therapy Resistant Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation
研究概览
简要总结
The aim of this prospective single-center study is to evaluate sympathetic nervous system directly measured by microneurography, 24-hour blood pressure, endothelial function, vascular compliance, quality of life and platelet adhesion in patients with sleep apnea syndrome (defined by a complaint of excessive daytime sleepiness, an Epworth sleepiness score>8[10], and an apnea/hypopnea index (AHI>15/h) before and after catheter-based radiofrequency ablation of renal nerve. If the selected patients are treated with CPAP, this therapy should be stable during the whole study time. Primary and secondary end-point will be measured before and 1, 3, 6 and 12 months after renal sympathetic denervation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation
时间窗: 6 and 12 months
The primary objective of this study is to evaluate sympathetic nervous system activity in patients with sleep apnea syndrome before and 6 and 12 months after catheter-based radiofrequency ablation therapy of the renal sympathetic-nerve system
次要结局
- Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation(1, 3, 6 12 months)
- Change in renal function (creatinin plasma level and GFR CKD-EPI Formula) before and after catheter-based renal denervation(1, 3, 6, 12)
- Change in 24-hour Holter and heart rate variability, echocardiogramm before and after catheter-based renal denervation(6 and 12 months)
- Change in sleep quality, pulse-oximetry, AHI, quality of life and subjective sleepiness with the Epworth sleepiness score before after catheter-based renal denervation(1, 3, 6 and 12 months)
- Change in vascular function and oxidative stress and inflammation parameters before and after catheter-based renal denervation(1, 3, 6, and 12 months)