Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-03-15 @ 11:36 PM
Study NCT ID:
NCT01538992
Status:
WITHDRAWN
Last Update Posted:
2013-07-24
First Post:
2012-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Denervation in Patients With Advanced Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'we could not fined enough patients for the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-23', 'studyFirstSubmitDate': '2012-02-16', 'studyFirstSubmitQcDate': '2012-02-21', 'lastUpdatePostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': '• Ventricular function as measured by Echocardiography • NYHA functional Class, 6 min walking test, biochemical test. • Renal function as measured by Glomerular Filtration Rate (GFR)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['renal denervation', 'heart failure'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.', 'detailedDescription': 'Primary Outcome Measures:\n\n• Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events\n\nSecondary Outcome Measures:\n\n• Ventricular function,NYHA functional Class, 6 min walking test, biochemical test and Renal function as measured by Glomerular Filtration Rate (GFR)\n\nEligibility Patients population: Volunteers, NYHA Class III-IV heart failure patients. Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart Failure patients NYHA Class III or IV\n* Left Ventricular Ejection Function \\< 35%\n* GFR \\> 45 mL/min/1.73m2\n* Optimal stable medical therapy\n\nExclusion Criteria:\n\n* Do not eligible renal artery anatomy for treatment as determined by Angiography, and\n* History of prior renal artery intervention\n* Single functioning kidney.\n* Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months\n* Systolic BP \\< 110mmHG Hospitalisation because of heart failure in last 3 weeks.'}, 'identificationModule': {'nctId': 'NCT01538992', 'briefTitle': 'Renal Denervation in Patients With Advanced Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Bursa Postgraduate Hospital'}, 'officialTitle': 'Phase 3 Study of Renal Denervation That Improves Symptoms of Heart Failure and Enhances Life Quality in Advanced Heart Failure', 'orgStudyIdInfo': {'id': 'Bursa YİEAH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'renal denervation', 'description': 'in this group percutaneous renal denervation with Standard steerable Mariner Radiofreqency ablation Catheter (5F or 7F)', 'interventionNames': ['Device: Standard steerable Marinr RF ablation Catheter (5F or 7F)']}, {'type': 'NO_INTERVENTION', 'label': 'medical thrapy', 'description': 'medical treatment'}], 'interventions': [{'name': 'Standard steerable Marinr RF ablation Catheter (5F or 7F)', 'type': 'DEVICE', 'otherNames': ['Renal ablation'], 'description': 'Intervention: Device: Standard steerable Mariner Radiofrequency ablation Catheter (5F or 7F)', 'armGroupLabels': ['renal denervation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'HASAN ARI, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Postgraduate Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Postgraduate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Cardiology Chief Intern', 'investigatorFullName': 'Hasan ARI', 'investigatorAffiliation': 'Bursa Postgraduate Hospital'}}}}