Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00422318
Status:
COMPLETED
Last Update Posted:
2007-01-15
First Post:
2007-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Hyperuricemia in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001553', 'term': 'Benzbromarone'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2005-12'}, 'lastUpdateSubmitDate': '2007-01-12', 'studyFirstSubmitDate': '2007-01-12', 'studyFirstSubmitQcDate': '2007-01-12', 'lastUpdatePostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'parameters of echocardiography at 16 weeks'}, {'measure': 'BNP levels at 16 weeks'}], 'secondaryOutcomes': [{'measure': 'parameters of glucose metabolism at 16 weeks'}, {'measure': 'Parameters of lipid metabolism at 16 weeks'}]}, 'conditionsModule': {'keywords': ['Heart Failure', 'Insulin', 'Metabolism', 'Pharmacology', 'Uric Acid'], 'conditions': ['Heart Failure', 'Hyperuricemia']}, 'referencesModule': {'references': [{'pmid': '19933411', 'type': 'DERIVED', 'citation': 'Ogino K, Kato M, Furuse Y, Kinugasa Y, Ishida K, Osaki S, Kinugawa T, Igawa O, Hisatome I, Shigemasa C, Anker SD, Doehner W. Uric acid-lowering treatment with benzbromarone in patients with heart failure: a double-blind placebo-controlled crossover preliminary study. Circ Heart Fail. 2010 Jan;3(1):73-81. doi: 10.1161/CIRCHEARTFAILURE.109.868604. Epub 2009 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and (II) to test the effect of lowering UA by uricosuric treatment in CHF.', 'detailedDescription': 'Hyperuricemia is often observed in patients with congestive heart failure (CHF). It has been reported that hyperuricemia is related to exercise capacity, inflammation markers and diastolic dysfunction in such patients. In addition, hyperuricemia in CHF relates to both symptomatic status (i.e. morbidity) as well as impaired prognosis (i.e. mortality). Hyperuricemia is likely to play an important role in the pathophysiology of CHF. Up-regulation of xanthine oxidase (XO) activity in CHF has been shown to contribute to higher uric acid (UA) in CHF and the therapeutic concept of XO inhibition has shown beneficial effects in a number of surrogate markers in these patients. The XO inhibition accounts for substantial decrease in oxygen radical load, the latter is discussed as the main benefit of XO inhibition treatment in hyperuricemic patients. However, whether high uric acid itself is important or merely a marker of XO activity (and hence of increased radical accumulation) is currently under discussion. Therefore, this study aims to assess (I) the contribution of UA itself to the CHF pathophysiology and (II) to test the effect of lowering UA by uricosuric treatment in CHF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic heart failure\n* hyperuricemia\n\nExclusion Criteria:\n\n* renal dysfunction (Cr \\> 2.0 mg/dl)\n* under treatment with anti-diabetic agents'}, 'identificationModule': {'nctId': 'NCT00422318', 'briefTitle': 'Treatment of Hyperuricemia in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Tottori University Hospital'}, 'officialTitle': 'Hyperuricemia and the Effects of the Uricosuric Agents Benzbromarone in Patients With Chronic Heart Failure', 'orgStudyIdInfo': {'id': '#345'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Benzbromarone (drug)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '683-8504', 'city': 'Yonago', 'country': 'Japan', 'facility': 'Tottori University Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 133.33333}}], 'overallOfficials': [{'name': 'Kazuhide Ogino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tottori University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tottori University Hospital', 'class': 'OTHER'}}}}