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

University of Zurich

Overview

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 Type

OBSERVATIONAL

Conditions

Therapy-resistant Hypertension and Sleep Apnea

Interventions

No intervention will be done. The study is observationalOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

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

Time frame: 6 and 12 months

Secondary Outcomes

Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation

Time frame: 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

Time frame: 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

Time frame: 1, 3, 6 and 12 months

Change in 24-hour Holter and heart rate variability, echocardiogramm before and after catheter-based renal denervation

Time frame: 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

Data from ClinicalTrials.gov

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