Effect of Catheter-based Radiofrequency Ablation Therapy of the Renal Sympathetic-Nerve System for Patient With Sleep Apnea Syndrome and Therapy Resistant Hypertension
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Therapy-resistant Hypertension and Sleep Apnea
- Sponsor
- University of Zurich
- Locations
- 1
- Primary Endpoint
- Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation
Time Frame: 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
Secondary Outcomes
- 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)