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Prognosis in Adult Patients with Congenital Heart Disease

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06723704
Acronym
PRO-ACHD
Enrollment
450
Registered
2024-12-09
Start date
2022-03-21
Completion date
2026-12-31
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Congenital Heart Disease

Keywords

adult congenital heart disease, ACHD, prognosis, long-term, follow-up

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.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
cardiovascular outcomes5 yearscomposite endpoint of death and cardiac hospitalization
major cardiac arrhytmias5 yearsoccurence of ventricular and/or atrial arrhythmias

Secondary

MeasureTime frameDescription
changes in echocardiographic parameters over time12 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 monthsprogression of pre-existing heart valve disease or new-onset valve dysfunction assessed through echocardiography

Countries

Italy

Contacts

Primary ContactFrancesca Graziani, MD, PhD
francesca.graziani@policlinicogemelli.it00390630154432
Backup ContactGiulia Iannaccone, MD
giulia.iannaccone@guest.policlinicogemelli.it00390630154432

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026