Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 1:30 PM
Study NCT ID:
NCT01128933
Status:
COMPLETED
Last Update Posted:
2010-05-24
First Post:
2010-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Fractional Flow Reserve in Renal Artery Stenting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012078', 'term': 'Renal Artery Obstruction'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-21', 'studyFirstSubmitDate': '2010-05-21', 'studyFirstSubmitQcDate': '2010-05-21', 'lastUpdatePostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure improvement', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Kidney function preservation', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fractional flow reserve', 'Revascularization', 'Prognosis', 'Hemodynamics', 'Hypertension'], 'conditions': ['Renal Artery Stenosis', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '25268986', 'type': 'DERIVED', 'citation': 'Kadziela J, Prejbisz A, Michalowska I, Adamczak M, Warchol-Celinska E, Pregowska-Chwala B, Januszewicz M, Wiecek A, Januszewicz A, Witkowski A. Relationship between hemodynamic parameters of renal artery stenosis and the changes of kidney function after renal artery stenting in patients with hypertension and preserved renal function. Blood Press. 2015 Feb;24(1):30-4. doi: 10.3109/08037051.2014.958304. Epub 2014 Sep 30.'}, {'pmid': '23913461', 'type': 'DERIVED', 'citation': 'Kadziela J, Januszewicz A, Prejbisz A, Michalowska I, Januszewicz M, Florczak E, Kalinczuk L, Norwa-Otto B, Warchol E, Witkowski A. Prognostic value of renal fractional flow reserve in blood pressure response after renal artery stenting (PREFER study). Cardiol J. 2013;20(4):418-22. doi: 10.5603/CJ.2013.0101.'}], 'seeAlsoLinks': [{'url': 'http://www.ikard.pl', 'label': 'Web page of Institute of Cardiology, Warsaw'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography\n* Hypertension defined according to WHO criteria\n* Age 18-75 years\n* Signed informed consent obtained\n\nExclusion Criteria:\n\n* Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney\n* Contraindications to percutaneous renal angioplasty with stenting\n* Atrophy of the kidney supplied with stenosed artery\n* Other well known secondary reason for hypertension\n* Chronic heart failure NYHA II-IV\n* Significant valvular heart disease qualified for surgery\n* Persistent atrial fibrillation\n* Renal failure with GFR below 30ml/min'}, 'identificationModule': {'nctId': 'NCT01128933', 'acronym': 'PREFFER', 'briefTitle': 'Renal Fractional Flow Reserve in Renal Artery Stenting', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Cardiology, Warsaw, Poland'}, 'officialTitle': 'Prognostic Value of Renal Fractional Flow Reserve in Hypertensive Patients With Renal Artery Stenosis Qualified to Renal Artery Stenting', 'orgStudyIdInfo': {'id': '2P05B02530'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypertensive patients', 'description': 'Hypertensive patients with at least moderate renal artery stenosis', 'interventionNames': ['Procedure: Renal artery stenting']}], 'interventions': [{'name': 'Renal artery stenting', 'type': 'PROCEDURE', 'armGroupLabels': ['Hypertensive patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-628', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Institute of Cardiology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Jacek Kadziela, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiology, Warsaw, Poland'}, {'name': 'Adam Witkowski, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiology, Warsaw, Poland'}, {'name': 'Andrzej Januszewicz, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Cardiology, Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cardiology, Warsaw, Poland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Higher Education, Poland', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Jacek Kadziela', 'oldOrganization': 'Institute of Cardiology, Warsaw, Poland'}}}}