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

Effect of Catheter-based Radiofrequency Ablation Therapy of the Renal Sympathetic-Nerve System for Patient With Sleep Apnea Syndrome and Therapy Resistant Hypertension

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.

Study Overview

• Status: Withdrawn
• Conditions: Therapy-resistant Hypertension and Sleep Apnea
• Intervention / Treatment: Other: No intervention will be done. The study is observational

• Study Type: Observational

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Division of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with therapy-resistant arterial hypertension and sleep apnea syndrome

Description

Inclusion criteria: We plan to include male or female subjects, age 18-80 with a diagnosis of medium-severe sleep apnea syndrome (defined by symptoms, a complaint of excessive daytime sleepiness, an Epworth sleepiness score >8, and an apnea / hypopnea index >15/h) and a resistant hypertension (systolic blood pressure >140 mmHg or >130 mmHg in patients with type II diabetes or chronic kidney disease, under treatment with three antihypertensive drugs including a diuretic).

If the selected patients are treated with CPAP, this therapy should be stable during the whole study time.

Every patient will be asked for a written informed consent.

Exclusion criteria: - Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure).

• Long acting nitrates, or PDE-5-Hemmer
• Alcohol or drug abuse,
• Malignancy (unless healed or remission > 5 years)
• Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
• Pulmonary Hypertension (PAP>50 mmHg)
• Pregnancy
• Anatomical contraindication to renal denervation
• Know allergy to contrast
• Participation in another study within the last month

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation	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	6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation	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	Change in creatinin plasma level and GFR CKD-EPI Formula before and after catheter-based renal denervation	1, 3, 6, 12
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 24-hour Holter and heart rate variability, echocardiogramm before and after catheter-based renal denervation		6 and 12 months
Change in vascular function and oxidative stress and inflammation parameters before and after catheter-based renal denervation	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	1, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Thomas Luescher, Professor, MD, University Hospital Zurich, Division of Cardiology

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: April 26, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimate): June 18, 2013

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Hypertension; Apnea
• Other Study ID Numbers: EK2012_0393