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Recruiting Observational

Prognosis in Adult Patients With Congenital Heart Disease

NCT06723704 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-03-21
Last updated
2024-12-09

Condition(s) studied

Adult Congenital Heart Disease

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • cardiovascular outcomes — 5 years
    composite endpoint of death and cardiac hospitalization
  • major cardiac arrhytmias — 5 years
    occurence of ventricular and/or atrial arrhythmias

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli Rome RM Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06723704 on ClinicalTrials.gov ↗ ← All trials in Italy