Prognosis in Adult Patients with Congenital Heart Disease

NCT06723704 | Recruiting

• 1 other identifier: 4742
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This is a mono-center observational ambispective study in which adult patients with congenital heart disease evaluated at our institution will be enrolled. 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.

Conditions

Adult Congenital Heart Disease

Keywords

adult congenital heart disease; ACHD; prognosis; long-term; follow-up

Outcome Measures

Primary Outcomes (2)

• cardiovascular outcomes

  composite endpoint of death and cardiac hospitalization

  5 years

• major cardiac arrhytmias

  occurence of ventricular and/or atrial arrhythmias

  5 years

Secondary Outcomes (2)

• changes in echocardiographic parameters over time

  12 months

• heart valve disease (new-onset or progression)

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pazients with congenital heart disease either untreated, corrected or palliated evaluated for the first time in our ACHD Oupatient Clinic during the study period

You may qualify if:

• Patients evaluated in our ACHD Outpatient Clinic between January 2014 and December 2026
• Age ≥ 18 years

You may not qualify if:

• Patients without congenital heart disease confirmed during the first evaluation
• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, RM, 00168, Italy

RECRUITING

Related Publications (6)

• 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: 24655794 BACKGROUND

• 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: 26369353 BACKGROUND

• 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: 30027209 BACKGROUND

• 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: 22078432 BACKGROUND

• 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: 11300418 BACKGROUND

• 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.

  PMID: 21098444 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Francesca Graziani, MD, PhD

CONTACT

00390630154432; francesca.graziani@policlinicogemelli.it

Giulia Iannaccone, MD

CONTACT

00390630154432; giulia.iannaccone@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 9, 2024
• Study Start: March 21, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)