Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-07 @ 6:42 PM
Study NCT ID:
NCT02608632
Status:
UNKNOWN
Last Update Posted:
2015-11-20
First Post:
2015-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HFS-guided Renal Ablation for Improving Outcome of Renal Denervation Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-19', 'studyFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of responders to renal denervation procedure', 'timeFrame': '12 month'}], 'secondaryOutcomes': [{'measure': 'complications rate', 'timeFrame': '12 month'}, {'measure': 'cross-over rate', 'timeFrame': '12 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Renal denervation', 'Ablation'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Office-based systolic blood pressure of ≥140/90 mm Hg and \\<160/100 mm Hg (moderate resistant hypertension) or ≥160/100 mm Hg (severe resistant hypertension), despite treatment with 3 antihypertensive drugs (including a diuretic).\n* A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula.\n\nExclusion Criteria:\n\n* Secondary causes of hypertension\n* Severe renal artery stenosis or dual renal arteries\n* Congestive heart failure\n* Left ventricular ejection fraction \\<35%\n* Previous renal artery stenting or angioplasty\n* Type 1 diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT02608632', 'briefTitle': 'HFS-guided Renal Ablation for Improving Outcome of Renal Denervation Procedure', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure', 'orgStudyIdInfo': {'id': '7452RDNHFS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (RDN guided by HFS)', 'description': 'Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. After that high-frequency stimulation (HFS) was used before the initial and after each radiofrequency (RF) delivery within the renal artery. RDN was considered to have been achieved when the sudden increase of blood pressure (\\> 15 mm Hg from invasive arterial monitoring) was eliminated in response to HFS.\n\nRF ablations of 8-12 watts (impedance drop \\>10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by \\> 5 mm) were performed both longitudinally and rotationally within each renal artery.', 'interventionNames': ['Device: Renal denervation guided by HFS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 (RDN as standard procedure)', 'description': 'Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access.\n\nRF ablations of 8-12 watts (impedance drop \\>10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by \\> 5 mm) were performed both longitudinally and rotationally within each renal artery. High-frequency stimulation (HFS) was performed before and after RDN to just to verify the response of BP', 'interventionNames': ['Device: Renal denervation as standard procedure']}], 'interventions': [{'name': 'Renal denervation guided by HFS', 'type': 'DEVICE', 'armGroupLabels': ['Group 1 (RDN guided by HFS)']}, {'name': 'Renal denervation as standard procedure', 'type': 'DEVICE', 'armGroupLabels': ['Group 2 (RDN as standard procedure)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'Federal Center of Cardiovascular surgery', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'Regional Hospital', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal Center of Prophylactic Medicine', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}