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

NCT ID: NCT01879566

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Therapy-resistant Hypertension and Sleep Apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention will be done. The study is observational

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Luescher, Professor, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Cardiology

Locations

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University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EK2012_0393

Identifier Type: -

Identifier Source: org_study_id