Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-04-23 @ 4:18 PM
Study NCT ID:
NCT02378857
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'EDTA, citrate and serum samples for analysis for vitamin status, biochemical analysis, inflammation markers and organ specific markers.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2015-02-27', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic status', 'timeFrame': 'Current at time of inclusion', 'description': 'Status as found by invasive and non-invasive assessment'}, {'measure': 'Structural and functional hepatic changes', 'timeFrame': 'Current at time of inclusion', 'description': 'Status as found by non-invasive assessment'}, {'measure': 'Cardio-pulmonary function and functional reserve', 'timeFrame': 'Current at time of inclusion', 'description': 'Status as found by non-invasive assessment'}, {'measure': 'Quality of life and psycho-social outcome', 'timeFrame': 'Current at time of inclusion', 'description': 'Status as found by questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Univentricular heart defect', 'Fontan circulation'], 'conditions': ['Congenital Heart Disease']}, 'referencesModule': {'references': [{'pmid': '34921324', 'type': 'DERIVED', 'citation': 'Moller T, Klungerbo V, Diab S, Holmstrom H, Edvardsen E, Grindheim G, Brun H, Thaulow E, Kohn-Luque A, Rosner A, Dohlen G. Circulatory Response to Rapid Volume Expansion and Cardiorespiratory Fitness in Fontan Circulation. Pediatr Cardiol. 2022 Apr;43(4):903-913. doi: 10.1007/s00246-021-02802-y. Epub 2021 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.', 'detailedDescription': 'A study group of 40-50 individuals will be investigated by non-invasive and invasive methods, including echocardiography at rest and during exercise, heart catheterization with advanced hemodynamic studies, cardiac and abdominal MRI, abdominal ultrasound and transient elastography, quality of life assessment and cardiopulmonary exercise testing. A selection of tests will be performed in a healthy control group as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adolescents i Norway with univentricular heart defects and Fontan type palliation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age, heart defect, heart surgery and type of palliation/correction, informed consent\n\nExclusion Criteria:\n\n* non-consenting, contraindications or increased risk to perform study tests (i.e. metal parts prohibiting MRI, motoric impairment prohibiting CPET)'}, 'identificationModule': {'nctId': 'NCT02378857', 'briefTitle': 'Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects', 'orgStudyIdInfo': {'id': '2013/1331 (REK)'}, 'secondaryIdInfos': [{'id': '2014077', 'type': 'OTHER', 'domain': 'South-Eastern Norway Regional Health Authority'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient group', 'description': 'Adolescents (15-18 years of age) With univentricular heart defects and Fontan type palliation.'}, {'label': 'Control group', 'description': 'Age- and gender-matched healthy individuals'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital, Rikshospitalet, Department of Paediatric Cardiology', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Thomas Moller, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital, University of Oslo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hospital for Sick Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant pediatric cardiologist, MD PhD', 'investigatorFullName': 'Thomas Möller', 'investigatorAffiliation': 'Oslo University Hospital'}}}}