Clinical trial NCT01879566: Effect of Catheter-based Radiofrequency Ablation Therapy in Patient With Therapy-resistant Hypertension and Sleep Apnea Syndrome
Official title: Effect of Catheter-based Radiofrequency Ablation Therapy of the Renal Sympathetic-Nerve System for Patient With Sleep Apnea Syndrome and Therapy Resistant Hypertension
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Therapy-resistant Hypertension and Sleep Apnea
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with therapy-resistant arterial hypertension and sleep apnea syndrome

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in sympathetic nervous system activity (burst/min and burst/100 HB) before and after catheter-based radiofrequency ablation
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation
timeFrame: 1, 3, 6 12 months
measure: Change in renal function (creatinin plasma level and GFR CKD-EPI Formula) before and after catheter-based renal denervation
timeFrame: 1, 3, 6, 12
measure: Change in sleep quality, pulse-oximetry, AHI, quality of life and subjective sleepiness with the Epworth sleepiness score before after catheter-based renal denervation
timeFrame: 1, 3, 6 and 12 months
measure: Change in 24-hour Holter and heart rate variability, echocardiogramm before and after catheter-based renal denervation
timeFrame: 6 and 12 months
measure: Change in vascular function and oxidative stress and inflammation parameters before and after catheter-based renal denervation
timeFrame: 1, 3, 6, and 12 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Cardiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Cardiology
name: Thomas Luescher, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References: