An observational study in Adult Congenital Heart Disease, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 450 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pazients with congenital heart disease either untreated, corrected or palliated evaluated for the first time in our ACHD Oupatient Clinic during the study period
Exclusion Criteria:
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.
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
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
Time frame: 12 months
Plan to share: No
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS