Prognosis in Adult Patients With Congenital Heart Disease
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Rome, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 450 people, planned
- Started
- 21 Mar 2022
- Expected to end
- 31 Dec 2026
- Type of study
- Observational
- Record updated
- 9 December 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Patients evaluated in our ACHD Outpatient Clinic between January 2014 and December 2026
- Age ≥ 18 years
Who cannot take part
- 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
Where in Italy
- Fondazione Policlinico Universitario Agostino GemelliRome, ItalyContact: Francesca Graziani, MD, PhDTaking people
About the trial
What the trial wants to find out
This is a mono-center observational ambispective study in which adult patients with congenital heart disease evaluated at our institution will be enrolled.
Read full original descriptionShow less
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.
The group in the trial
- 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prognosis in Adult Patients With Congenital Heart Disease: an Observational Study
- Record updated
- 9 December 2024