Prognosis in Adult Patients with Congenital Heart Disease

Recruiting

• Conditions: Adult Congenital Heart Disease

• Registration Number: NCT06723704
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-21
• Study First Submitted: 2024-11-28
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiovascular outcomes	5 years	composite endpoint of death and cardiac hospitalization
major cardiac arrhytmias	5 years	occurence of ventricular and/or atrial arrhythmias

Secondary Outcome Measures

Name	Time	Method
changes in echocardiographic parameters over time	12 months	* 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)	12 months	progression of pre-existing heart valve disease or new-onset valve dysfunction assessed through echocardiography

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, RM, Italy