Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-21 @ 11:15 AM
Study NCT ID:
NCT00984932
Status:
COMPLETED
Last Update Posted:
2009-09-25
First Post:
2009-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-24', 'studyFirstSubmitDate': '2009-09-24', 'studyFirstSubmitQcDate': '2009-09-24', 'lastUpdatePostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise capacity measured by the SMWT, mPAP and WHO functional class change', 'timeFrame': 'At baseline and After 6 months of therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['systemic sclerosis', 'pulmonary hypertension', 'rosuvastatin'], 'conditions': ['Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'Although the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event and statins through their vasculoprotective effect might be of value in the treatment armamentarium of PAH related to SSc.\n\nThe aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.', 'detailedDescription': 'Background: Pulmonary arterial hypertension (PAH) is an acknowledged devastating complication of systemic sclerosis (SSc); difficult to manage with a poor prognosis.\n\nAlthough the aetiology of SSc-PAH remains elusive, vascular dysfunction seems to be the initial event.\n\nStatins, through their pleotropic effects might be of value in the treatment armamentarium of PAH related to SSc.\n\nObjectives: The aim was to assess the efficacy of rosuvastatin in ameliorating vascular dysfunction and in the management of SSc-related PAH.\n\nMethods: Forty SSc patients fulfilling the ACR criteria for the classification of SSc diagnosis and having PAH were recruited.\n\nAll SSc patients underwent transthoracic echocardiography and the six minute walk test (SMWT).\n\nPatients were randomized into 2 groups; the first group (n = 23) were assigned to receive 40mg of rosuvastatin and the second group (n = 23) received placebo for 6 months.\n\nThe levels of endothelial dysfunction and inflammatory markers were assayed at baseline and after 6 months of therapy. Outcome measures assessed included exercise capacity (SMWT), MPAP, WHO functional class change, tolerability and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New York Heart Association (NYHA) class III\n* A mean pulmonary artery pressure (mPAP) of \\> 30mmHg at rest\n\nExclusion Criteria:\n\n* Smoking\n* Diabetes mellitus\n* Hypercholesterolemia\n* Hypertension\n* Cardiac insufficiency\n* Coexisting hepatic and renal diseases\n* Use of drugs known to interact with statins.\n* Patients with severe interstitial lung fibrosis'}, 'identificationModule': {'nctId': 'NCT00984932', 'briefTitle': 'Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'The Effect of Rosuvastatin on Vascular Dysfunction and Inflammatory Markers in Systemic Sclerosis-related Pulmonary Hypertension: Randomized, Double-Blind Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'alexmed116613963'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin', 'interventionNames': ['Drug: Rosuvastatin']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Statin, Crestor'], 'description': '40 mg of rosuvastatin daily', 'armGroupLabels': ['Rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '203', 'city': 'Alexandria', 'state': 'Alexandria Governorate', 'country': 'Egypt', 'facility': 'Faculty of Medicine, University of Alexandria', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Anna Abou-Raya', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alexandria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alexandria', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Anna Abou-Raya', 'oldOrganization': 'Faculty of Medicine, University of Alexandria'}}}}