Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 9:56 PM
Study NCT ID:
NCT00782327
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2008-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2014-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2008-10-29', 'studyFirstSubmitQcDate': '2008-10-29', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The decrease of rate of aortic root growth measured by echocardiography at level of sinuses of Valsalva. The measure will be expressed in mm of growth per year and as Z-score.', 'timeFrame': 'At baseline and after 6 months, 1, 2 and 3 years follow-up'}], 'secondaryOutcomes': [{'measure': 'Comparative arterial stiffness', 'timeFrame': 'At baseline and after 6 months, 1, 2 and 3 years follow-up'}, {'measure': 'Evaluation of progression of aortic regurgitation', 'timeFrame': 'At baseline and after 6 months, 1, 2 and 3 years follow-up'}, {'measure': 'Aortic dissection incidence', 'timeFrame': 'At baseline and after 6 months, 1, 2 and 3 years follow-up'}, {'measure': 'Aortic root surgery', 'timeFrame': 'At baseline and after 6 months, 1, 2 and 3 years follow-up'}, {'measure': 'Progression of mitral regurgitation', 'timeFrame': 'At baseline and after 6 months, 1, 2 and 3 years follow-up'}, {'measure': 'Left ventricular size and function', 'timeFrame': 'At baseline and after 6 months, 1, 2 and 3 years follow-up'}, {'measure': 'Skeletal and somatic traits', 'timeFrame': 'At baseline and after 6 months, 1, 2 and 3 years follow-up'}, {'measure': 'Quality of life', 'timeFrame': 'At baseline and after 6 months, 1, 2 and 3 years follow-up'}, {'measure': 'Genetic polymorphisms affecting clinical symptoms and response to treatment', 'timeFrame': 'End of study'}, {'measure': 'Death', 'timeFrame': 'At baseline and after 6 months, 1, 2 and 3 years follow-up'}, {'measure': 'Aortic stiffness as assessed by MRI', 'timeFrame': 'At baseline and after 1 year and 3 years follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Marfan Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website of the University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'To study the effect of losartan (an angiotensin receptor blocker-ARB) on aortic root growth in patients with Marfan syndrome, already treated with beta-blockers (BB). The effect of losartan will be compared to placebo. Losartan or placebo will be added to the treatment regimen in a two-step up-titration scheme over 2 weeks. Start doses of Losartan will be 25 mg for subjects under 50kg of weight and 50mg if the weight is over 50kg. Uptitration will be guided by the tolerance of the drug by the patients. Patients will be contacted by phone call for assessment of side-effects before second step of uptitration.\n\nDaily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 10 years\n* Diagnosis of MFS, according to the Ghent criteria and/or genetically proven FBN1 mutations or linkage\n* Consent obtained (written) either for the patient and for his/her parents (\\<18y\n* Z-score of the aorta at the level of the sinus of Valsalva ≥2 (BSA adjusted)\n* ARB naïve patients\n\nExclusion Criteria:\n\n* Poor echocardiographic window,limiting the accurate measurement of the aortic root\n* Contra-indication for ARB: Bilateral renal artery stenosis, renal function abnormalities (creatinine above normal for age), hyperkalemia\n* Intolerance for ARB (eg angioedema)\n* Pregnancy or breast feeding women\n* Absence of effective contraception\n* Liver function abnormalities\n* Heart Failure\n* Patients included in other clinical trial'}, 'identificationModule': {'nctId': 'NCT00782327', 'briefTitle': 'Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers', 'orgStudyIdInfo': {'id': '2008/503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Losartan', 'interventionNames': ['Drug: Losartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Losartan', 'type': 'DRUG', 'description': 'Daily maximal doses of Losartan will be 50mg for subjects under 50kg of weight and 100mg if the weight is over 50kg', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Daily placebo capsule', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Julie De Backer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agentschap voor Innovatie door Wetenschap en Technologie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}