Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT05288894
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2022-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repaired Tetralogy of Fallot Italian Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013771', 'term': 'Tetralogy of Fallot'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '6 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-11', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '6 years', 'description': 'Number of Participants with cardiac-releted death'}], 'secondaryOutcomes': [{'measure': 'Hospitalizations', 'timeFrame': '6 years', 'description': 'Rate of cardiac-related hospitalizations due to cardiac arrhythmias or cardaio failure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tetralogy of Fallot', 'Cardiac Death, Sudden', 'Cardiac Arrhythmia', 'Cardiac Event']}, 'referencesModule': {'references': [{'pmid': '7617503', 'type': 'BACKGROUND', 'citation': 'Hoffman JI. Incidence of congenital heart disease: I. Postnatal incidence. Pediatr Cardiol. 1995 May-Jun;16(3):103-13. doi: 10.1007/BF00801907.'}, {'pmid': '24076489', 'type': 'BACKGROUND', 'citation': 'Villafane J, Feinstein JA, Jenkins KJ, Vincent RN, Walsh EP, Dubin AM, Geva T, Towbin JA, Cohen MS, Fraser C, Dearani J, Rosenthal D, Kaufman B, Graham TP Jr; Adult Congenital and Pediatric Cardiology Section, American College of Cardiology. Hot topics in tetralogy of Fallot. J Am Coll Cardiol. 2013 Dec 10;62(23):2155-66. doi: 10.1016/j.jacc.2013.07.100. Epub 2013 Sep 27.'}, {'pmid': '21251297', 'type': 'BACKGROUND', 'citation': 'Geva T. Repaired tetralogy of Fallot: the roles of cardiovascular magnetic resonance in evaluating pathophysiology and for pulmonary valve replacement decision support. J Cardiovasc Magn Reson. 2011 Jan 20;13(1):9. doi: 10.1186/1532-429X-13-9.'}, {'pmid': '24065609', 'type': 'BACKGROUND', 'citation': 'Geva T. Indications for pulmonary valve replacement in repaired tetralogy of fallot: the quest continues. Circulation. 2013 Oct 22;128(17):1855-7. doi: 10.1161/CIRCULATIONAHA.113.005878. Epub 2013 Sep 24. No abstract available.'}, {'pmid': '15028368', 'type': 'BACKGROUND', 'citation': 'Geva T, Sandweiss BM, Gauvreau K, Lock JE, Powell AJ. Factors associated with impaired clinical status in long-term survivors of tetralogy of Fallot repair evaluated by magnetic resonance imaging. J Am Coll Cardiol. 2004 Mar 17;43(6):1068-74. doi: 10.1016/j.jacc.2003.10.045.'}, {'pmid': '29538684', 'type': 'BACKGROUND', 'citation': 'Samad MD, Wehner GJ, Arbabshirani MR, Jing L, Powell AJ, Geva T, Haggerty CM, Fornwalt BK. Predicting deterioration of ventricular function in patients with repaired tetralogy of Fallot using machine learning. Eur Heart J Cardiovasc Imaging. 2018 Jul 1;19(7):730-738. doi: 10.1093/ehjci/jey003.'}, {'pmid': '26276804', 'type': 'BACKGROUND', 'citation': 'Wald RM, Valente AM, Gauvreau K, Babu-Narayan SV, Assenza GE, Schreier J, Gatzoulis MA, Kilner PJ, Koyak Z, Mulder B, Powell AJ, Geva T. Cardiac magnetic resonance markers of progressive RV dilation and dysfunction after tetralogy of Fallot repair. Heart. 2015 Nov;101(21):1724-30. doi: 10.1136/heartjnl-2015-308014. Epub 2015 Aug 14.'}, {'pmid': '24945055', 'type': 'BACKGROUND', 'citation': "Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. Report No.: 13(14)-EHC111. Available from http://www.ncbi.nlm.nih.gov/books/NBK208616/"}, {'pmid': '15549361', 'type': 'BACKGROUND', 'citation': 'Trojano M. Can databasing optimise patient care? J Neurol. 2004 Sep;251 Suppl 5:v79-v82. doi: 10.1007/s00415-004-1513-x.'}, {'pmid': '34147117', 'type': 'BACKGROUND', 'citation': 'Ravaglioli A, Ait-Ali L, Federici D, Salvadori S, Pllumi A, Pak V, Marrone C, Pizzuto A, Bonhoeffer P, Festa P. The impact of native Fallot anatomy on future therapeutic requirements and outcomes at follow-up. Cardiovasc Ultrasound. 2021 Jun 19;19(1):23. doi: 10.1186/s12947-021-00249-y.'}, {'pmid': '33934202', 'type': 'BACKGROUND', 'citation': 'Clemente EA, Casares AP, Frontera PR, Calvar JMC, de Toledo JS. Finding the Optimal Timing for Repair of Standard Tetralogy of Fallot: Analysis of Cardiac Magnetic Resonance and Echocardiography Parameters Related to Intermediate Term Outcomes in a Pediatric Population. Pediatr Cardiol. 2021 Aug;42(6):1324-1333. doi: 10.1007/s00246-021-02615-z. Epub 2021 May 2.'}, {'pmid': '31272701', 'type': 'BACKGROUND', 'citation': 'Egbe AC, Kothapalli S, Borlaug BA, Ammash NM, Najam M, Bajwa N, Tarek K, Mathew J, Connolly HM. Mechanism and Risk Factors for Death in Adults With Tetralogy of Fallot. Am J Cardiol. 2019 Sep 1;124(5):803-807. doi: 10.1016/j.amjcard.2019.05.048. Epub 2019 Jun 7.'}, {'pmid': '27803032', 'type': 'BACKGROUND', 'citation': 'Bokma JP, Winter MM, Vehmeijer JT, Vliegen HW, van Dijk AP, van Melle JP, Meijboom FJ, Post MC, Zwinderman AH, Mulder BJ, Bouma BJ. QRS fragmentation is superior to QRS duration in predicting mortality in adults with tetralogy of Fallot. Heart. 2017 May;103(9):666-671. doi: 10.1136/heartjnl-2016-310068. Epub 2016 Nov 1.'}, {'pmid': '9436772', 'type': 'BACKGROUND', 'citation': 'Berul CI, Hill SL, Geggel RL, Hijazi ZM, Marx GR, Rhodes J, Walsh KA, Fulton DR. Electrocardiographic markers of late sudden death risk in postoperative tetralogy of Fallot children. J Cardiovasc Electrophysiol. 1997 Dec;8(12):1349-56. doi: 10.1111/j.1540-8167.1997.tb01031.x.'}, {'pmid': '24468055', 'type': 'BACKGROUND', 'citation': 'Valente AM, Cook S, Festa P, Ko HH, Krishnamurthy R, Taylor AM, Warnes CA, Kreutzer J, Geva T. Multimodality imaging guidelines for patients with repaired tetralogy of fallot: a report from the AmericanSsociety of Echocardiography: developed in collaboration with the Society for Cardiovascular Magnetic Resonance and the Society for Pediatric Radiology. J Am Soc Echocardiogr. 2014 Feb;27(2):111-41. doi: 10.1016/j.echo.2013.11.009. No abstract available.'}, {'pmid': '15044866', 'type': 'BACKGROUND', 'citation': 'Toyono M, Harada K, Tamura M, Yamamoto F, Takada G. Myocardial acceleration during isovolumic contraction as a new index of right ventricular contractile function and its relation to pulmonary regurgitation in patients after repair of tetralogy of Fallot. J Am Soc Echocardiogr. 2004 Apr;17(4):332-7. doi: 10.1016/j.echo.2003.12.022.'}, {'pmid': '30121239', 'type': 'BACKGROUND', 'citation': 'Stout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, Crumb SR, Dearani JA, Fuller S, Gurvitz M, Khairy P, Landzberg MJ, Saidi A, Valente AM, Van Hare GF. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Apr 2;73(12):e81-e192. doi: 10.1016/j.jacc.2018.08.1029. Epub 2018 Aug 16. No abstract available.'}, {'pmid': '16061735', 'type': 'BACKGROUND', 'citation': 'Diller GP, Dimopoulos K, Okonko D, Li W, Babu-Narayan SV, Broberg CS, Johansson B, Bouzas B, Mullen MJ, Poole-Wilson PA, Francis DP, Gatzoulis MA. Exercise intolerance in adult congenital heart disease: comparative severity, correlates, and prognostic implication. Circulation. 2005 Aug 9;112(6):828-35. doi: 10.1161/CIRCULATIONAHA.104.529800. Epub 2005 Aug 1.'}, {'pmid': '32860028', 'type': 'BACKGROUND', 'citation': 'Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K; ESC Scientific Document Group. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021 Feb 11;42(6):563-645. doi: 10.1093/eurheartj/ehaa554. No abstract available.'}, {'pmid': '17607499', 'type': 'BACKGROUND', 'citation': 'Festa P, Ait-Ali L, Prontera C, De Marchi D, Fontana M, Emdin M, Passino C. Amino-terminal fragment of pro-brain natriuretic hormone identifies functional impairment and right ventricular overload in operated tetralogy of Fallot patients. Pediatr Cardiol. 2007 Sep-Oct;28(5):339-45. doi: 10.1007/s00246-007-0009-8. Epub 2007 Jun 29.'}, {'pmid': '25351509', 'type': 'BACKGROUND', 'citation': 'Heng EL, Bolger AP, Kempny A, Davlouros PA, Davidson S, Swan L, Uebing A, Pennell DJ, Gatzoulis MA, Babu-Narayan SV. Neurohormonal activation and its relation to outcomes late after repair of tetralogy of Fallot. Heart. 2015 Mar;101(6):447-54. doi: 10.1136/heartjnl-2014-306398. Epub 2014 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'The CMR/CT WG of the Italian pediatric cardiology society set up a multi-center observational clinical database of repaired-TOF evaluated. This registry will enroll prospectively patients evaluated by CMR for clinical indication in most of the CHD Italian centers. Data collection will include surgical history, clinical data, imaging data, and also adverse cardiac events for a period of 6 years.', 'detailedDescription': 'This is an observational prospective registry that will enroll patients presenting with repaired Tetralogy of Fallot (TOF) undergoing a cardiac magnetic resonance (CMR) imaging study in our recruiting CMR-Laboratories.\n\nCMR imaging studies will include the evaluation of biventricular volumes and function, atrial volumes and function, and the Late Gadolinium Enhancement (LGE), along with the evaluation of the anatomy and flow of the main pulmonary arteries and branches. We will also assess the aortic valve for regurgitation and measurement of the aortic size.\n\nAt follow-up, any interventional or surgical procedures performed and symptoms or any major (Death) and cardiac (cardiac-related hospitalization) events will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a repaired-TOF without associated complex pathology underwent CMR imaging.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Repaired - TOF\n\nExclusion Criteria:\n\n* Age \\< 10 years\n* Other associated complex pathology such as MAPCAs, Atrioventricular canal, Ebstein\n* Incomplete CMR exam'}, 'identificationModule': {'nctId': 'NCT05288894', 'acronym': 'RETE-Fallot', 'briefTitle': 'Repaired Tetralogy of Fallot Italian Registry', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero, Universitaria Ospedali Riuniti'}, 'officialTitle': 'Multicenter Italian Registry From the Italian Pediatric Cardiology Society (SICP) Working Group (WG) on CMR/CT for the Repaired Tetralogy of Fallot', 'orgStudyIdInfo': {'id': 'SICP WG CMR/CT 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Repaired Tetralogy of Fallot', 'description': 'A patient affected by Tetralogy of Fallot (right ventricle outflow obstruction, right ventricle hypertrophy, ventricular septal defect, aortic overriding of the ventricular defect) that already underwent cardiac surgery for the correction.', 'interventionNames': ['Diagnostic Test: Cardiac magnetic resonance imaging']}], 'interventions': [{'name': 'Cardiac magnetic resonance imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'A routine cardiac magnetic resonance imaging with biventricular function evaluation, atrial volumes, LGE acquisitions, and pulmonary and aortic assesment.', 'armGroupLabels': ['Repaired Tetralogy of Fallot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60123', 'city': 'Ancona', 'state': 'The Marches', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Bianco, M.D.', 'role': 'CONTACT', 'email': 'francesco.bianco@ospedaliriuniti.marche.it', 'phone': '+39 071 596 5316'}], 'facility': 'CCPC', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero, Universitaria Ospedali Riuniti', 'class': 'OTHER'}, 'collaborators': [{'name': 'SICP WG CMR/CT', 'class': 'UNKNOWN'}, {'name': 'Fondazione Toscana Gabriele Monasterio', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Francesco Bianco', 'investigatorAffiliation': 'Azienda Ospedaliero, Universitaria Ospedali Riuniti'}}}}