Effect of Catheter-based Radiofrequency Ablation Therapy in Patient With Therapy-resistant Hypertension and Sleep Apnea Syndrome

Withdrawn

• Conditions: Therapy-resistant Hypertension and Sleep Apnea

• Registration Number: NCT01879566
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-04-26
• Study Start: 2013-05
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-18
• Primary Completion: 2017-04
• Study Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation	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 Outcome Measures

Name	Time	Method
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 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation
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 creatinin plasma level and GFR CKD-EPI Formula before and after catheter-based renal denervation
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	Change in vascular function (endothelial function as flow mediated dilatation, arterial stiffness by pulse wave velocity) and oxidative stress and inflammation parameters before and after catheter-based renal denervation

Trial Locations

Locations (1)

University Hospital Zurich, Division of Cardiology; 🇨🇭 Zurich, ZH, Switzerland