Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT01785732
Status:
UNKNOWN
Last Update Posted:
2013-02-11
First Post:
2013-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-02-05', 'lastUpdatePostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Office blood pressure', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Ambulatory blood pressure', 'timeFrame': '2 years'}, {'measure': 'Insulin resistance', 'timeFrame': '2 years'}, {'measure': 'Endothelial function', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Resistant Hypertension']}, 'descriptionModule': {'briefSummary': 'Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based renal denervation causes substantial and sustained blood- pressure reduction in patients with resistant hypertension.\n\nThe purpose of RENSYMPIS is to study the effects of renal denervation on:\n\n1. Cardiovascular function\n2. Metabolic factors\n3. Inflammatory and endocrine factors\n4. Coagulation\n5. Sleep'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resistant Hypertension (systolic blood pressure \\>160mmHg and 3 or more antihypertensive agents in use)\n* Age 30- 69 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Secondary hypertension\n* Pseudohypertension\n* Pregnancy\n* Renal insufficiency (GFR \\<45ml/min)\n* Clinically significant stenotic valvular disease\n* Oral anticoagulation\n* CCS III-IV symptoms or CABG/PCI in previous 6 months\n* Prior stroke\n* Contrast agent allergy\n* inappropriate renal artery anatomy (\\< 4mm diameter, \\< 20mm length)'}, 'identificationModule': {'nctId': 'NCT01785732', 'acronym': 'RENSYMPIS', 'briefTitle': 'Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital District of Satakunta'}, 'orgStudyIdInfo': {'id': 'SA-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Renal denervation', 'description': 'Patients are randomized to renal denervation', 'interventionNames': ['Procedure: Renal Denervation']}, {'type': 'NO_INTERVENTION', 'label': 'Optimization of medical therapy', 'description': 'Antihypertensive treatment is optimized'}], 'interventions': [{'name': 'Renal Denervation', 'type': 'PROCEDURE', 'description': 'Sympathetic renal denervation via renal arteries', 'armGroupLabels': ['Renal denervation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pori', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Tuomas Paana, M.D', 'role': 'CONTACT', 'email': 'tuomas.paana@satshp.fi', 'phone': '+358 2 6277100'}, {'name': 'Tuomas Paana, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antti Ylitalo, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Risto Kaaja, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Satakunta Central Hospital', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}], 'centralContacts': [{'name': 'Tuomas Paana, M.D.', 'role': 'CONTACT', 'email': 'tuomas.paana@satshp.fi', 'phone': '+358 2 6277100'}, {'name': 'Antti Ylitalo, M.D. Ph.D', 'role': 'CONTACT', 'email': 'antti.ylitalo@satshp.fi', 'phone': '+358 2 6277100'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital District of Satakunta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}