About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients evaluated in our ACHD Outpatient Clinic between January 2014 and December 2026
Age ≥ 18 years
Disqualifiers
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 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
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
cardiovascular outcomes
composite endpoint of death and cardiac hospitalization
major cardiac arrhytmias
occurence of ventricular and/or atrial arrhythmias
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).
heart valve disease (new-onset or progression)
progression of pre-existing heart valve disease or new-onset valve dysfunction assessed through echocardiography
Sponsors and contacts
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