Evaluating long-term outcomes in adults with congenital heart disease
Official title: Prognosis in Adult Patients With Congenital Heart Disease: an Observational Study
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06723704 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, RM) |
| Status | Recruiting |
| Started | March 21, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 9, 2024 |
| Trial ID | NCT06723704 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have been evaluated for congenital heart disease at the outpatient clinic.
✕Probably not a fit
Patients without congenital heart disease or those who cannot provide consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar observational studies have been conducted, this specific approach focusing on long-term outcomes in adults with congenital heart disease is relatively novel.
Who can join: the full rules
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 it's running
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Fondazione Policlinico Universitario Agostino Gemelli
Rome, Rm, Italy Recruiting
Study contacts
- Study coordinator: Francesca Graziani, MD, PhD
- Email: francesca.graziani@policlinicogemelli.it
- Phone: 00390630154432
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Heart Institute Biobank and Registry for Adults with Congenital Heart Disease and Related Conditions
This project will collect blood, tissue samples, and detailed health information from adults (≥16) with congenital heart disease and related heart or vascular conditions to create a resource researchers can use.
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Evaluating cardiac resynchronization therapy effects in adults with congenital heart disease
This study is trying to see if cardiac resynchronization therapy can help adults with congenital heart disease feel better and improve their heart function.
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Trauma, PTSD, and resilience in adults living with congenital heart disease
This project will test whether lifetime experiences related to congenital heart disease are linked to PTSD and whether resilience helps protect adults with CHD.
-
Evaluating the effectiveness of SGLT2 inhibitors in adults with congenital heart disease
This study is trying to see if a new type of diabetes medication can help adults with congenital heart disease feel better and manage their heart failure symptoms.
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Identifying noninvasive markers of heart transplant rejection in patients with congenital heart disease
This study is testing a new blood test to see if it can help detect heart transplant rejection in patients with congenital heart disease without needing a more invasive procedure.
-
Observational study of adults with congenital heart disease
This study looks at how adults with congenital heart disease are managed at a specialized center to see how their health is doing and what kind of care they need.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.