Prognosis in Adult Patients with Congenital Heart Disease (PRO-ACHD)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Adult Congenital Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT06723704

4742

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

450 participants in 1 patient group

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.