Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-03-16 @ 4:54 AM
Study NCT ID:
NCT01879566
Status:
WITHDRAWN
Last Update Posted:
2017-10-25
First Post:
2013-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Catheter-based Radiofrequency Ablation Therapy in Patient With Therapy-resistant Hypertension and Sleep Apnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2013-04-26', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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'}], 'secondaryOutcomes': [{'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', 'description': 'Change in 24-hour blood pressure (24 hour, day and night mean) before and after catheter-based renal denervation'}, {'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', 'description': 'Change in creatinin plasma level and GFR CKD-EPI Formula before and after catheter-based renal denervation'}, {'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', 'description': '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'}]}, 'conditionsModule': {'conditions': ['Therapy-resistant Hypertension and Sleep Apnea']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with therapy-resistant arterial hypertension and sleep apnea syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': '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).\n\nIf the selected patients are treated with CPAP, this therapy should be stable during the whole study time.\n\nEvery patient will be asked for a written informed consent.\n\nExclusion criteria: - Heart failure (normal ejection fractions on echocardiography and no clinical signs and symptoms of heart failure).\n\n* Long acting nitrates, or PDE-5-Hemmer\n* Alcohol or drug abuse,\n* Malignancy (unless healed or remission \\> 5 years)\n* Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)\n* Pulmonary Hypertension (PAP\\>50 mmHg)\n* Pregnancy\n* Anatomical contraindication to renal denervation\n* Know allergy to contrast\n* Participation in another study within the last month'}, 'identificationModule': {'nctId': 'NCT01879566', 'briefTitle': 'Effect of Catheter-based Radiofrequency Ablation Therapy in Patient With Therapy-resistant Hypertension and Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of Catheter-based Radiofrequency Ablation Therapy of the Renal Sympathetic-Nerve System for Patient With Sleep Apnea Syndrome and Therapy Resistant Hypertension', 'orgStudyIdInfo': {'id': 'EK2012_0393'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention will be done. The study is observational', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Division of Cardiology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Thomas Luescher, Professor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}