Prognosis in Adult Patients with Congenital Heart Disease
NCT ID: NCT06723704
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2022-03-21
2026-12-31
Brief Summary
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The primary endopoint is to assess the clinical and echocardiographic predictors of adverse events during follow-up (death, arrhythmias, cardiac hospitalization).
The 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.
Participants 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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ACHD cohort
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
Exclusion Criteria
* Impossibility to retrieve information about the first clinical evaluation in our clinic from our electonic datasets
* Follow up shorter than one-year
* Refused consent to participate to the study.
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Graziani Francesca
MD, PhD
Locations
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Fondazione Policlinico Universitario Agostino Gemelli
Rome, RM, Italy
Countries
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Central Contacts
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Facility Contacts
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Francesca Graziani, MD, PhD
Role: primary
Giulia Iannaccone, MD
Role: backup
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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4742
Identifier Type: -
Identifier Source: org_study_id