Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT00837603
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2009-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physical Training in Transposition of the Great Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014188', 'term': 'Transposition of Great Vessels'}, {'id': 'D004062', 'term': 'DiGeorge Syndrome'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'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'}, {'id': 'D058165', 'term': '22q11 Deletion Syndrome'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D044148', 'term': 'Lymphatic Abnormalities'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D007011', 'term': 'Hypoparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-08', 'studyFirstSubmitDate': '2009-02-04', 'studyFirstSubmitQcDate': '2009-02-04', 'lastUpdatePostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac MRI Right Ventricular Ejection Fraction', 'timeFrame': '6 and 12 months'}, {'measure': 'Cardiopulmonary exercise capacity', 'timeFrame': '6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'laboratory markers of heart failure', 'timeFrame': '6 and 12 months'}, {'measure': 'Diastolic RV and LV function', 'timeFrame': '6 and 12 months'}, {'measure': 'Right ventricular volumes', 'timeFrame': '6 and 12 months'}, {'measure': 'Right ventricular mass', 'timeFrame': '6 and 12 months'}, {'measure': 'NYHA-class', 'timeFrame': '6 and 12 months'}, {'measure': 'quality of life questionnaire', 'timeFrame': '6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tga', 'atrial switch', 'training'], 'conditions': ['Transposition of Great Vessels']}, 'referencesModule': {'references': [{'pmid': '24207068', 'type': 'DERIVED', 'citation': 'Westhoff-Bleck M, Schieffer B, Tegtbur U, Meyer GP, Hoy L, Schaefer A, Tallone EM, Tutarel O, Mertins R, Wilmink LM, Anker SD, Bauersachs J, Roentgen P. Aerobic training in adults after atrial switch procedure for transposition of the great arteries improves exercise capacity without impairing systemic right ventricular function. Int J Cardiol. 2013 Dec 5;170(1):24-9. doi: 10.1016/j.ijcard.2013.10.009. Epub 2013 Oct 11.'}, {'pmid': '23711443', 'type': 'DERIVED', 'citation': 'Tutarel O, Rontgen P, Bode-Boger SM, Martens-Lobenhoffer J, Westhoff-Bleck M, Diller GP, Bauersachs J, Kielstein JT. Symmetrical dimethylarginine is superior to NT-proBNP for detecting systemic ventricular dysfunction in adults after atrial repair for transposition of the great arteries. Int J Cardiol. 2013 Oct 9;168(4):4415-6. doi: 10.1016/j.ijcard.2013.05.030. Epub 2013 May 24. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'In transposition patients after atrial switch operation, the morphological right ventricle serves as the systemic ventricle. These patients often develop signs of heart failure. It is not known, whether physical training can safely be recommended in these patients- like heart failure guidelines recommend training in patients with normal anatomy. Furthermore it is not known, whether these TGA-patients benefit from training with respect to cardiopulmonary exercise capacity.', 'detailedDescription': 'This is a randomized, controlled, prospective trial on the safety of physical training in TGA patients after atrial switch operation.\n\nIn transposition patients after atrial switch operation, the morphological right ventricle serves as the systemic ventricle. These patients often develop signs of heart failure. It is not known, whether physical training can safely be recommended in these patients- like heart failure guidelines recommend training in patients with normal anatomy. Furthermore it is not known, whether these TGA-patients benefit from training with respect to cardiopulmonary exercise capacity.\n\nPrimary endpoints are Systemic Ventricle Ejection Fraction and Volumes, Exercise Capacity.\n\nSecondary endpoints are Echo Diastolic Function, as well as laboratory markers of heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>=18 years\n\nExclusion Criteria:\n\n* tricuspid regurgitation grade 2 or more\n* sign. LVOTO or RVOTO\n* pacemaker or defibrillator\n* recent hospitalisation for heart failure (90 days)'}, 'identificationModule': {'nctId': 'NCT00837603', 'acronym': 'TrainingTGA', 'briefTitle': 'Physical Training in Transposition of the Great Arteries', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Influence of Physical Training on Cardiopulmonary Exercise Capacity and Right Ventricular Function in Patients With D-TGA and Atrial Switch Operation.', 'orgStudyIdInfo': {'id': 'TGA2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Training', 'description': 'Ergometer Training', 'interventionNames': ['Behavioral: Training']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Counseling'}], 'interventions': [{'name': 'Training', 'type': 'BEHAVIORAL', 'otherNames': ['ergometer', 'physical exercise'], 'description': 'Controlled home ergometer training', 'armGroupLabels': ['Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30623', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Philip Roentgen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}, {'name': 'Gerd P Meyer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hannover Medical School'}, {'name': 'Helmut Drexler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Helmut Drexler, MD, Professor of Medicine', 'oldOrganization': 'Hannover Medical School'}}}}