Prognosis in Adult Patients With Congenital Heart Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

450 Participants
are grouped into 1 trial group
Group A: ACHD cohort

Trial outcomes

Primary outcomes

1

cardiovascular outcomes

composite endpoint of death and cardiac hospitalization

Time frame
5 years
2

major cardiac arrhytmias

occurence of ventricular and/or atrial arrhythmias

Time frame
5 years

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

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