Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-21 @ 12:19 AM
Study NCT ID:
NCT01887067
Status:
TERMINATED
Last Update Posted:
2022-11-18
First Post:
2013-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Slow recruitment and change in clinical evidence', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2013-06-24', 'studyFirstSubmitQcDate': '2013-06-25', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in office systolic & diastolic blood pressure from baseline to 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change in office systolic and diastolic blood pressure up to 3 years', 'timeFrame': '3 years'}, {'measure': 'Change in insulin sensitivity', 'timeFrame': '12 months', 'description': 'HOMA-IR index at baseline, 3-month and 12-month'}, {'measure': 'Change in glucose metabolism', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypertension', 'Diabetes Mellitus'], 'conditions': ['Hypertension, Resistant', 'Diabetes Mellitus', 'Renal Denervation Therapy']}, 'descriptionModule': {'briefSummary': 'To demonstrate the efficacy of renal denervation therapy in treating resistant hypertension and its effect on glucose metabolism in patients with type 2 diabetes mellitus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ranges from 18 to 70 years inclusive\n* Essential hypertension\n* Office Systolic BP (SBP) ≥ 150 mmHg or Diastolic BP (DBP) ≥ 90mmHg\n* 3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications\n* Type 2 Diabetes Mellitus on oral hypoglycaemic agent (OHA)\n* 2 functional kidneys; eGFR ≥ 45 mL/min/1.73m² (MDRD formula)\n* Suitable renal anatomy compatible with the endovascular denervation procedure\n\nExclusion Criteria:\n\n* Individual has renal artery anatomy that is ineligible for treatment including:\n* Patients with secondary hypertension\n* Myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months\n* Patient with type 1 diabetes mellitus\n* Patient on insulin due to oral drug failure\n* Renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries)\n* Pregnancy\n* Patient with any implantable device incompatible with radiofrequency energy delivery\n* Hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous\n* Any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely'}, 'identificationModule': {'nctId': 'NCT01887067', 'acronym': 'HTN2DM', 'briefTitle': 'Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Pamela Youde Nethersole Eastern Hospital'}, 'officialTitle': 'Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'HKEC-2012-038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal denervation therapy', 'interventionNames': ['Procedure: Renal denervation therapy']}], 'interventions': [{'name': 'Renal denervation therapy', 'type': 'PROCEDURE', 'otherNames': ['Renal denervation using Symplicity® Catheter System™'], 'armGroupLabels': ['Renal denervation therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Pamela Youde Nethersole Eastern Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Kin Lam Tsui, FRCP (Edin, Glasg)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pamela Youde Nethersole Eastern Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamela Youde Nethersole Eastern Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Physician', 'investigatorFullName': 'Kin Lam TSUI', 'investigatorAffiliation': 'Pamela Youde Nethersole Eastern Hospital'}}}}