Evaluating long-term outcomes in adults with congenital heart disease
Prognosis in Adult Patients With Congenital Heart Disease: an Observational Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06723704
This study looks at adults with congenital heart disease to see what factors might lead to serious health issues over time, while they continue their regular check-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT06723704 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adult patients with congenital heart disease who are evaluated at a specialized outpatient clinic. It aims to identify clinical and echocardiographic predictors of adverse events such as death, arrhythmias, and hospitalizations during follow-up. The study will also assess the incidence of specific adverse events and the impact of acquired heart conditions that develop over time. Participants will be monitored during their routine follow-up visits without any additional interventions beyond standard clinical care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been evaluated for congenital heart disease at the outpatient clinic.
Not a fit: Patients without congenital heart disease or those who cannot provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of long-term outcomes in adults with congenital heart disease, leading to better management strategies.
How similar studies have performed: While similar observational studies have been conducted, this specific approach focusing on long-term outcomes in adults with congenital heart disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome, RM
- Fondazione Policlinico Universitario Agostino Gemelli — Rome, RM, Italy (RECRUITING)
Study contacts
- Study coordinator: Francesca Graziani, MD, PhD
- Email: francesca.graziani@policlinicogemelli.it
- Phone: 00390630154432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adult Congenital Heart Disease, adult congenital heart disease, ACHD, prognosis, long-term, follow-up