Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 6:24 AM
Study NCT ID:
NCT06723704
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis in Adult Patients with Congenital Heart Disease
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiovascular outcomes', 'timeFrame': '5 years', 'description': 'composite endpoint of death and cardiac hospitalization'}, {'measure': 'major cardiac arrhytmias', 'timeFrame': '5 years', 'description': 'occurence of ventricular and/or atrial arrhythmias'}], 'secondaryOutcomes': [{'measure': 'changes in echocardiographic parameters over time', 'timeFrame': '12 months', 'description': '* variations in cardiac chamber size (volumes in ml, diameters in mm);\n* variations in left ventricular function (assessed as left ventricular ejection fraction in % using the Simpson biplane method);\n* variations in right ventricular systolic function (assessed as tricuspid anular plane systolic excursion in mm).'}, {'measure': 'heart valve disease (new-onset or progression)', 'timeFrame': '12 months', 'description': 'progression of pre-existing heart valve disease or new-onset valve dysfunction assessed through echocardiography'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adult congenital heart disease', 'ACHD', 'prognosis', 'long-term', 'follow-up'], 'conditions': ['Adult Congenital Heart Disease']}, 'referencesModule': {'references': [{'pmid': '24655794', 'type': 'BACKGROUND', 'citation': 'Lin YS, Liu PH, Wu LS, Chen YM, Chang CJ, Chu PH. Major adverse cardiovascular events in adult congenital heart disease: a population-based follow-up study from Taiwan. BMC Cardiovasc Disord. 2014 Mar 21;14:38. doi: 10.1186/1471-2261-14-38.'}, {'pmid': '26369353', 'type': 'BACKGROUND', 'citation': 'Diller GP, Kempny A, Alonso-Gonzalez R, Swan L, Uebing A, Li W, Babu-Narayan S, Wort SJ, Dimopoulos K, Gatzoulis MA. Survival Prospects and Circumstances of Death in Contemporary Adult Congenital Heart Disease Patients Under Follow-Up at a Large Tertiary Centre. Circulation. 2015 Dec 1;132(22):2118-25. doi: 10.1161/CIRCULATIONAHA.115.017202. Epub 2015 Sep 14.'}, {'pmid': '30027209', 'type': 'BACKGROUND', 'citation': 'Lytzen R, Vejlstrup N, Bjerre J, Petersen OB, Leenskjold S, Dodd JK, Jorgensen FS, Sondergaard L. Live-Born Major Congenital Heart Disease in Denmark: Incidence, Detection Rate, and Termination of Pregnancy Rate From 1996 to 2013. JAMA Cardiol. 2018 Sep 1;3(9):829-837. doi: 10.1001/jamacardio.2018.2009.'}, {'pmid': '22078432', 'type': 'BACKGROUND', 'citation': 'van der Linde D, Konings EE, Slager MA, Witsenburg M, Helbing WA, Takkenberg JJ, Roos-Hesselink JW. Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J Am Coll Cardiol. 2011 Nov 15;58(21):2241-7. doi: 10.1016/j.jacc.2011.08.025.'}, {'pmid': '11300418', 'type': 'BACKGROUND', 'citation': 'Warnes CA, Liberthson R, Danielson GK, Dore A, Harris L, Hoffman JI, Somerville J, Williams RG, Webb GD. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001 Apr;37(5):1170-5. doi: 10.1016/s0735-1097(01)01272-4. No abstract available.'}, {'pmid': '21098444', 'type': 'BACKGROUND', 'citation': 'Moons P, Bovijn L, Budts W, Belmans A, Gewillig M. Temporal trends in survival to adulthood among patients born with congenital heart disease from 1970 to 1992 in Belgium. Circulation. 2010 Nov 30;122(22):2264-72. doi: 10.1161/CIRCULATIONAHA.110.946343. Epub 2010 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'This is a mono-center observational ambispective study in which adult patients with congenital heart disease evaluated at our institution will be enrolled.\n\nThe primary endopoint is to assess the clinical and echocardiographic predictors of adverse events during follow-up (death, arrhythmias, cardiac hospitalization).\n\nThe secondary endpoints are: 1) evaluation of the incidence of the singular components of the primary endpoint; 2) evaluation of the prognostic impact of acquired lesions, including valve disease not present at birth; 3) need for surgical/percutaneous interventions during follow up.\n\nParticipants will be evaluated in the context of scheduled follow-up visits in our Outpatient ACHD Clinic. No interventions/drug administration will be performed other than those required by standard clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pazients with congenital heart disease either untreated, corrected or palliated evaluated for the first time in our ACHD Oupatient Clinic during the study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients evaluated in our ACHD Outpatient Clinic between January 2014 and December 2026\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Patients without congenital heart disease confirmed during the first evaluation\n* Impossibility to retrieve information about the first clinical evaluation in our clinic from our electonic datasets\n* Follow up shorter than one-year\n* Refused consent to participate to the study.'}, 'identificationModule': {'nctId': 'NCT06723704', 'acronym': 'PRO-ACHD', 'briefTitle': 'Prognosis in Adult Patients with Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Prognosis in Adult Patients with Congenital Heart Disease: an Observational Study', 'orgStudyIdInfo': {'id': '4742'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ACHD cohort', 'description': 'Adult patients with congenital heart disease either untreated, corrected or palliated, evaluated in our ACHD Outpatient Clinic between 2014 and 2026 with at least one-year follow-up.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Graziani, MD, PhD', 'role': 'CONTACT', 'email': 'francesca.graziani@policlinicogemelli.it', 'phone': '00390630154432'}, {'name': 'Giulia Iannaccone, MD', 'role': 'CONTACT', 'email': 'giulia.iannaccone@guest.policlinicogemelli.it', 'phone': '00390630154432'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Francesca Graziani, MD, PhD', 'role': 'CONTACT', 'email': 'francesca.graziani@policlinicogemelli.it', 'phone': '00390630154432'}, {'name': 'Giulia Iannaccone, MD', 'role': 'CONTACT', 'email': 'giulia.iannaccone@guest.policlinicogemelli.it', 'phone': '00390630154432'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Graziani Francesca', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}