NCT06723704 Prognosis in Adult Patients With Congenital Heart Disease
| NCT ID | NCT06723704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Adult Congenital Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2022-03-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2022-03-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06723704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adult Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06723704 currently recruiting?
Yes, NCT06723704 is actively recruiting participants. Contact the research team at francesca.graziani@policlinicogemelli.it for enrollment information.
Where is the NCT06723704 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06723704 clinical trial?
NCT06723704 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 450 participants.