Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT03050112
Status:
COMPLETED
Last Update Posted:
2017-11-22
First Post:
2017-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-20', 'studyFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2017-02-08', 'lastUpdatePostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MacNew questionnaire', 'timeFrame': '30 minutes', 'description': 'Quality of life assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MacNew questionnaire', 'Quality of life'], 'conditions': ['Congenital Heart Disease']}, 'referencesModule': {'references': [{'pmid': '20923595', 'type': 'BACKGROUND', 'citation': 'Wauthy P, Massaut J, Sanoussi A, Demanet H, Morissens M, Damry N, Dessy H, Malekzadeh-Milani SG, Deuvaert FE. Ten-year experience with surgical treatment of adults with congenital cardiac disease. Cardiol Young. 2011 Feb;21(1):39-45. doi: 10.1017/S1047951110001332. Epub 2010 Oct 6.'}, {'pmid': '12067950', 'type': 'BACKGROUND', 'citation': 'Lane DA, Lip GY, Millane TA. Quality of life in adults with congenital heart disease. Heart. 2002 Jul;88(1):71-5. doi: 10.1136/heart.88.1.71.'}, {'pmid': '15785299', 'type': 'BACKGROUND', 'citation': 'Immer FF, Althaus SM, Berdat PA, Saner H, Carrel TP. Quality of life and specific problems after cardiac surgery in adolescents and adults with congenital heart diseases. Eur J Cardiovasc Prev Rehabil. 2005 Apr;12(2):138-43. doi: 10.1097/01.hjr.0000159318.62466.dc.'}, {'pmid': '23388149', 'type': 'BACKGROUND', 'citation': 'Fteropoulli T, Stygall J, Cullen S, Deanfield J, Newman SP. Quality of life of adult congenital heart disease patients: a systematic review of the literature. Cardiol Young. 2013 Aug;23(4):473-85. doi: 10.1017/S1047951112002351. Epub 2013 Feb 6.'}, {'pmid': '23955787', 'type': 'BACKGROUND', 'citation': 'Apers S, Luyckx K, Moons P. Quality of life in adult congenital heart disease: what do we already know and what do we still need to know? Curr Cardiol Rep. 2013 Oct;15(10):407. doi: 10.1007/s11886-013-0407-x.'}, {'pmid': '14713315', 'type': 'BACKGROUND', 'citation': 'Hofer S, Lim L, Guyatt G, Oldridge N. The MacNew Heart Disease health-related quality of life instrument: a summary. Health Qual Life Outcomes. 2004 Jan 8;2:3. doi: 10.1186/1477-7525-2-3.'}, {'pmid': '25453715', 'type': 'BACKGROUND', 'citation': 'Pavy B, Iliou MC, Hofer S, Verges-Patois B, Corone S, Aeberhard P, Curnier D, Henry J, Ponchon-Weess A, Oldridge N. Validation of the French version of the MacNew heart disease health-related quality of life questionnaire. Arch Cardiovasc Dis. 2015 Feb;108(2):107-17. doi: 10.1016/j.acvd.2014.09.006. Epub 2014 Nov 12.'}, {'pmid': '12018740', 'type': 'BACKGROUND', 'citation': 'Dixon T, Lim LL, Oldridge NB. The MacNew heart disease health-related quality of life instrument: reference data for users. Qual Life Res. 2002 Mar;11(2):173-83. doi: 10.1023/a:1015005109731.'}]}, 'descriptionModule': {'briefSummary': 'Adults with a congenital heart disease, having undergone a surgical intervention or a re-do surgery in adulthood, are a growing group of subjects in the general population. This increase is explained by improved medical and surgical techniques, with a better survival rate as outcome.\n\nThere is nowadays a growing interest in the quality of life of this group of subjects. However, studies give contradictory results. This can be explained on one hand by the vast majority of pathologies within this population, and on the other hand by the absence of a cardio-specific tool for quality of life measurement.\n\nThe MacNew questionnaire is cardio-specific. It allows an evaluation of the quality of life based on the exploration of three domains: physical, emotional and social.\n\nThe aim of this study is:\n\n* to evaluate the quality of life of these patients, by using the MacNew questionnaire\n* to explore the needs in terms of prevention, treatment and multi-disciplinary follow-up\n* to assess the mortality within this group of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT03050112', 'briefTitle': 'Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Long-term Quality of Life of Patients With a Congenital Heart Disease, Treated by Surgery in Adulthood at the Brugmann Hospital.', 'orgStudyIdInfo': {'id': 'CHUB-QOL cardiopathy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Congenital cardiopathy', 'description': 'Patients having had surgery in adulthood for a congenital heart disease, at the Brugmann University Hospital. The group consists in patients aged 16 years or older, having had surgery between 01/01/1998 and 31/12/2015.', 'interventionNames': ['Other: MacNew questionnaire']}], 'interventions': [{'name': 'MacNew questionnaire', 'type': 'OTHER', 'description': 'Patients will be asked to fill in the MacNew questionnaire on quality of life (phone contact).', 'armGroupLabels': ['Congenital cardiopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Halit Ozel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}, {'name': 'Pierre Wauthy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Brugmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Wauthy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of clinic', 'investigatorFullName': 'Pierre Wauthy', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}