Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-09 @ 4:10 PM
Study NCT ID:
NCT02164435
Status:
UNKNOWN
Last Update Posted:
2014-06-16
First Post:
2014-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-12', 'studyFirstSubmitDate': '2014-06-12', 'studyFirstSubmitQcDate': '2014-06-12', 'lastUpdatePostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Function (evaluated by MRI)', 'timeFrame': 'Baseline and 6 Months', 'description': 'MRI Indices of Cardiac Function\n\n* Myocardial mass and myocardial fibrosis\n* Atrial and ventricular ejection function\n* Myocardial perfusion\n* Arterial distensibility'}], 'secondaryOutcomes': [{'measure': 'Renal Function (evaluated by MRI)', 'timeFrame': 'Baseline, 6 Months and 24 Months', 'description': 'MRI Indices of Renal Function:\n\n* Renal blood flow\n* Renal perfusion\n* Urinary protein'}, {'measure': 'Cardiac Function', 'timeFrame': 'Baseline and 24 Months', 'description': 'MRI Indices of Cardiac Function\n\n* Myocardial mass and myocardial fibrosis\n* Atrial and ventricular ejection function\n* Myocardial perfusion\n* Arterial distensibility'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uncontrolled hypertension', 'Renal denervation', 'Renal artery'], 'conditions': ['Uncontrolled Hypertension']}, 'referencesModule': {'references': [{'pmid': '29627741', 'type': 'DERIVED', 'citation': 'Delacroix S, Chokka RG, Nelson AJ, Wong DT, Pederson S, Nimmo J, Rajwani A, Williams K, Teo KS, Worthley SG. Effects of renal sympathetic denervation on myocardial structure, function and perfusion: A serial CMR study. Atherosclerosis. 2018 May;272:207-215. doi: 10.1016/j.atherosclerosis.2018.03.022. Epub 2018 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, single centre clinical investigation looking at short (6 months) and long term (24 months) changes in cardiac function and renal function in patients with drug-resistant hypertension post renal sympathetic denervation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be able and willing to comply with the required follow-up schedule\n* Therapeutic Goods Association approved indications for EnligHTN™ Renal Denervation System\n* Subject is ≥ 18 years of age at time of consent Subject has office SBP ≥ 160 mmHg (except for subjects with Diabetes Mellitus who must demonstrate an office SBP of ≥ 150 mm Hg) within 14 days of the procedure ◦Subject is taking ≥ 3 antihypertensive medications concurrently at maximum tolerated dose (this must include one diuretic) or subject has a documented intolerance to at least 2 out of the 4 major classes of anti-hypertensives (ACE/ARB, CCB, Diuretics, Beta Blockers and is unable to take 3 antihypertensive drugs.\n\nExclusion Criteria:\n\n* Standard CMR exclusions;\n\n * implanted cardiac device\n * intracranial metallic implants\n * claustrophobia -Gadolinium-specific: estimated GFR \\<60 mls/min (usual clinical cut-off is \\<30 mls/min).\n* Adenosine-specific:\n\n * asthma / reactive airways disease\n * \\>first degree atrioventricular block\n * concomitant use of dipyridamole or theophylline consumption of caffeine within 48 hours of proposed investigation\n * EnligHTN™ Renal Denervation System exclusion criteria:\n\nSubject has an identified cause of secondary hypertension\n\n* Subject has an estimated GFR \\<45 mL/min per 1.73 m2 using the MDRD formula\n* Subject has undergone prior renal angioplasty, indwelling renal stents, and/or aortic stent grafts\n* Subject has haemodynamically significant valvular heart disease\n* Subject has a life expectancy less than 12 months, as determined by the PI\n* Subject is participating in another clinical study Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods\n* Subject has renal arteries with diameter(s) \\< 4 mm in diameter'}, 'identificationModule': {'nctId': 'NCT02164435', 'acronym': 'RDN', 'briefTitle': 'Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'University of Adelaide'}, 'officialTitle': 'Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation', 'orgStudyIdInfo': {'id': 'CI-12-044-AU-HT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Renal Denervation', 'interventionNames': ['Procedure: Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.']}], 'interventions': [{'name': 'Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.', 'type': 'PROCEDURE', 'armGroupLabels': ['Renal Denervation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Joanne Nimmo', 'role': 'CONTACT', 'email': 'joanne.nimmo@health.sa.gov.au', 'phone': '08 8222 2899'}, {'name': 'Stephen Worthley, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Adelaide Hospital Adelaide', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'centralContacts': [{'name': 'Stephen G Worthley, Prof', 'role': 'CONTACT', 'email': 'stephen.worthley@adelaide.edu.au'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Adelaide', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Helpman Chair of Cardiovascular Medicine', 'investigatorFullName': 'Stephen Grant Worthley', 'investigatorAffiliation': 'University of Adelaide'}}}}