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

• Sponsor: University of Zurich (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01879566
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 50
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Therapy-resistant Hypertension and Sleep Apnea	Other: No intervention will be done. The study is observational

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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 Start Date: May 1, 2013
• Anticipated Primary Completion Date: Apr 1, 2017
• Anticipated Study Completion Date: Jul 1, 2017

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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]

4. Change in 24-hour Holter and heart rate variability, echocardiogramm before and after catheter-based renal denervation [6 and 12 months]

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Division of Cardiology	Zurich	ZH	Switzerland	8091

Sponsors and Collaborators

• University of Zurich

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT01879566
• Other Study ID Numbers: EK2012_0393
• First Posted: Jun 18, 2013
• Last Update Posted: Oct 25, 2017
• Last Verified: Oct 1, 2017

• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Hypertension

Study Results

No Results Posted as of Oct 25, 2017