Prognosis in Adult Patients With Congenital Heart Disease

Fondazione Policlinico Universitario Agostino Gemelli IRCCS450 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

450

Conditions

Adult Congenital Heart Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Outcomes

Primary Outcomes

cardiovascular outcomes

composite endpoint of death and cardiac hospitalization

Time frame: 5 years

major cardiac arrhytmias

occurence of ventricular and/or atrial arrhythmias

Time frame: 5 years

Secondary Outcomes

changes in echocardiographic parameters over time

* variations in cardiac chamber size (volumes in ml, diameters in mm); * variations in left ventricular function (assessed as left ventricular ejection fraction in % using the Simpson biplane method); * variations in right ventricular systolic function (assessed as tricuspid anular plane systolic excursion in mm).

Time frame: 12 months

heart valve disease (new-onset or progression)

progression of pre-existing heart valve disease or new-onset valve dysfunction assessed through echocardiography