Prognosis in Adult Patients with Congenital Heart Disease: an Observational Study

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients evaluated in our ACHD Outpatient Clinic between January 2014 and December 2026

• Age ≥ 18 years

Locations
Other Locations
Italy
Fondazione Policlinico Universitario Agostino Gemelli
RECRUITING
Rome
Contact Information
Primary
Francesca Graziani, MD, PhD
francesca.graziani@policlinicogemelli.it
00390630154432
Backup
Giulia Iannaccone, MD
giulia.iannaccone@guest.policlinicogemelli.it
00390630154432
Time Frame
Start Date: 2022-03-21
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 450
Treatments
ACHD cohort
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.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov