Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 12:30 PM
Study NCT ID:
NCT02920034
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2016-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2016-09-24', 'studyFirstSubmitQcDate': '2016-09-28', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daytime blood pressure change', 'timeFrame': '3 months after Intervention', 'description': 'Daytime blood pressure change in ambulatory blood pressure measurement'}], 'secondaryOutcomes': [{'measure': 'General blood pressure change', 'timeFrame': '3 months after Intervention', 'description': 'Change in 24 h average blood pressure change in ambulatory blood pressure measurement'}, {'measure': 'Daytime blood pressure change', 'timeFrame': '6 months after Intervention', 'description': 'Daytime blood pressure change in ambulatory blood pressure measurement'}, {'measure': 'General blood pressure change', 'timeFrame': '6 months after Intervention', 'description': 'Change in 24 h average blood pressure change in ambulatory blood pressure measurement'}, {'measure': 'Daytime blood pressure change', 'timeFrame': '12 months after Intervention', 'description': 'Daytime blood pressure change in ambulatory blood pressure measurement'}, {'measure': 'Daytime blood pressure change', 'timeFrame': '24 months after Intervention', 'description': 'Daytime blood pressure change in ambulatory blood pressure measurement'}, {'measure': 'General blood pressure change', 'timeFrame': '12 months after Intervention', 'description': 'Change in 24 h average blood pressure change in ambulatory blood pressure measurement'}, {'measure': 'General blood pressure change', 'timeFrame': '24 months after Intervention', 'description': 'Change in 24 h average blood pressure change in ambulatory blood pressure measurement'}, {'measure': 'Exercise blood pressure change', 'timeFrame': '3 months after Intervention', 'description': 'Change in exercise blood pressure on bicycle stress testing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Therapy Resistant Hypertension']}, 'referencesModule': {'references': [{'pmid': '36792266', 'type': 'DERIVED', 'citation': 'Fengler K, Rommel KP, Kriese W, Blazek S, Besler C, von Roeder M, Desch S, Thiele H, Lurz P. 6- and 12-Month Follow-Up From a Randomized Clinical Trial of Ultrasound vs Radiofrequency Renal Denervation (RADIOSOUND-HTN). JACC Cardiovasc Interv. 2023 Feb 13;16(3):367-369. doi: 10.1016/j.jcin.2022.10.058. No abstract available.'}, {'pmid': '31203726', 'type': 'DERIVED', 'citation': 'Fengler K, Rommel KP, Lapusca R, Blazek S, Besler C, Hartung P, von Roeder M, Kresoja KP, Desch S, Thiele H, Lurz P. Renal Denervation in Isolated Systolic Hypertension Using Different Catheter Techniques and Technologies. Hypertension. 2019 Aug;74(2):341-348. doi: 10.1161/HYPERTENSIONAHA.119.13019. Epub 2019 Jun 17.'}, {'pmid': '30586691', 'type': 'DERIVED', 'citation': 'Fengler K, Rommel KP, Blazek S, Besler C, Hartung P, von Roeder M, Petzold M, Winkler S, Hollriegel R, Desch S, Thiele H, Lurz P. A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN). Circulation. 2019 Jan 29;139(5):590-600. doi: 10.1161/CIRCULATIONAHA.118.037654.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, randomized trial to assess the effectiveness of different renal sympathetic denervation methods (radiofrequency main vs. branches + main vs. ultrasound based) in a cohort of patients with therapy refractory arterial hypertension and large renal arteries', 'detailedDescription': 'The aim of this trial is a prospective, randomized comparison of three different techniques for catheter based renal sympathetic denervation. Patients with larger (\\>5.5 mm) renal arteries are randomized to a treatment with a radiofrequency based catheter of the main renal artery, the main renal artery, its side-branches and accessories or an ultrasound-based denervation of the main renal artery only. The primary endpoint is the change in daytime blood pressure acquired in ambulatory blood pressure measurement at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with resistant hypertension (≥3 antihypertensive drugs including at least one diuretic, without any dosage change in the preceding 4 weeks) and a systolic office blood pressure of \\>160 mmHg, ≥1 main renal artery diameter \\>5.5 mm\n\nExclusion Criteria:\n\n* pregnancy, known renal artery stenosis, average systolic daytime RR \\<135 mmHg in 24h ambulatory blood pressure measurement (ABPM), ≥1 renal artery diameter \\<4.0 mm, life-expectancy \\<6 months, participation in any other clinical trial.'}, 'identificationModule': {'nctId': 'NCT02920034', 'acronym': 'RADIOSOUND', 'briefTitle': 'Randomized Comparison of Ultrasound Versus Radiofrequency Denervation in Patients With Therapy Resistant Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Heart Center Leipzig - University Hospital'}, 'officialTitle': 'A Randomized Comparison of Ultrasound Based Versus Radiofrequency Based Catheter Ablation Techniques in Patients With Therapy Resistant Arterial Hypertension With Large Renal Arteries', 'orgStudyIdInfo': {'id': 'Radiosound 1.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Radiofrequency main renal artery', 'description': 'Renal sympathetic denervation of the main renal artery using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA)', 'interventionNames': ['Device: Radiofrequency denervation of the main renal arteries']}, {'type': 'EXPERIMENTAL', 'label': 'Radiofrequency main and branches', 'description': 'Renal sympathetic denervation of the main renal artery, its branches and accessories using the radiofrequency-based Spyral™ catheter (Medtronic, MN, USA)', 'interventionNames': ['Device: Radiofrequency denervation of renal arteries and branches']}, {'type': 'EXPERIMENTAL', 'label': 'Ultrasound main renal artery', 'description': 'Renal sympathetic denervation of the main renal artery using the ultrasound-based Paradise™ catheter (ReCor, CA, USA)', 'interventionNames': ['Device: Ultrasound denervation of the main renal arteries']}], 'interventions': [{'name': 'Radiofrequency denervation of the main renal arteries', 'type': 'DEVICE', 'description': 'Catheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA)', 'armGroupLabels': ['Radiofrequency main renal artery']}, {'name': 'Radiofrequency denervation of renal arteries and branches', 'type': 'DEVICE', 'description': 'Catheter based renal sympathetic denervation of the main renal arteries and its branches using the Spyral™ Catheter (Medtronic, MN, USA)', 'armGroupLabels': ['Radiofrequency main and branches']}, {'name': 'Ultrasound denervation of the main renal arteries', 'type': 'DEVICE', 'description': 'Catheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA)', 'armGroupLabels': ['Ultrasound main renal artery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Heart Center of the University Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Philipp C Lurz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center of the University Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart Center Leipzig - University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Investigator, Professor, Managing Senior Physician', 'investigatorFullName': 'Philipp Lurz', 'investigatorAffiliation': 'Heart Center Leipzig - University Hospital'}}}}