Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-03-29 @ 8:38 AM
Study NCT ID:
NCT00485368
Status:
COMPLETED
Last Update Posted:
2007-06-13
First Post:
2007-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008382', 'term': 'Marfan Syndrome'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020913', 'term': 'Perindopril'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-12', 'studyFirstSubmitDate': '2007-06-11', 'studyFirstSubmitQcDate': '2007-06-12', 'lastUpdatePostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'aortic root diameter', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'arterial stiffness', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['marfan syndrome', 'aortic root diameter'], 'conditions': ['Marfan Syndrome']}, 'referencesModule': {'references': [{'pmid': '17911499', 'type': 'DERIVED', 'citation': "Ahimastos AA, Aggarwal A, D'Orsa KM, Formosa MF, White AJ, Savarirayan R, Dart AM, Kingwell BA. Effect of perindopril on large artery stiffness and aortic root diameter in patients with Marfan syndrome: a randomized controlled trial. JAMA. 2007 Oct 3;298(13):1539-47. doi: 10.1001/jama.298.13.1539.", 'retractions': [{'pmid': '26594834', 'source': 'JAMA. 2015 Dec 22-29;314(24):2692-3'}]}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to assess the effects of a drug called perindopril on the aorta in people known to have Marfan Syndrome. The aorta is the major artery of the body that comes out of the heart and supplies blood to the body. We know that in people with Marfan Syndrome, the aorta is stiff and this stiffness results in its enlargement over many years. This enlargement of the aorta can be very serious. We know from treatment of other heart conditions that drugs of the same type as perindopril reduce stiffness of the arteries. This type of drug has never been tried in people with Marfan Syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-40\n* Diagnosis of Marfan Syndrome, on the basis of the Ghent Criteria\n\nExclusion Criteria:\n\n* Age \\<18, \\>40\n* Women of child-bearing potential not on adequate contraception\n* Serum creatinine of \\>0.11\n* A history of intolerance to ACEI\n* Patients on angiotensin receptor blockers\n* Blood pressure \\>140/90mmHg\n* History of previous aortic surgery'}, 'identificationModule': {'nctId': 'NCT00485368', 'briefTitle': 'Angiotensin Converting Enzyme Inhibitors in Marfan Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': 'The Effect of an Angiotensin Converting Enzyme Inhibitor on Aortic Wall Properties in Patients With Marfan Syndrome.', 'orgStudyIdInfo': {'id': '3/03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Coversyl (perindopril)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bronwyn A Kingwell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baker Heart Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Baker Heart Research Institute', 'class': 'OTHER'}, {'name': 'The Alfred', 'class': 'OTHER'}]}}}