Observational study of adults with congenital heart disease
Official title: Observational Cohort Study of Adult Patients With Congenital Heart Disease
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06769529 · Data updated 2026-11-12
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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | April 18, 2024 |
| Main results expected | May 1, 2025 |
| Study ends | May 1, 2025 |
| Registry record updated | January 31, 2025 |
| Trial ID | NCT06769529 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with congenital heart disease, either in natural history or those who have undergone previous surgical interventions since February 14, 2014.
✕Probably not a fit
Patients under 18 years old or those unable to provide longitudinal data after the first follow-up 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 aims to evaluate the management of adult patients with congenital heart disease (ACHD) at a specialized center. It will collect clinical and epidemiological data from patients, focusing on their health outcomes, healthcare resource utilization, and quality of life. The study will involve both retrospective and prospective data collection without any additional interventions beyond standard clinical practice. The goal is to understand the natural history of ACHD and the need for future interventions.
Why it matters
Potential benefit: If successful, this study could improve the management and care strategies for adults with congenital heart disease.
How similar studies have gone: Other studies have shown success in similar observational approaches, indicating the potential for valuable insights in managing congenital heart disease.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with congenital heart disease in natural history or previously undergoing palliative or corrective surgery in the time period after 14/02/2014 * Obtaining informed consent Exclusion Criteria: * Age \< 18 years * Inability to obtain longitudinal data after the first follow-up performed at our Center.
Where it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy Recruiting
Study contacts
- Principal investigator: Gabriele Egidy Assenza, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Gabriele Egidy Assenza, MD
- Email: gabriele.egidyassenza@aosp.bo.it
- Phone: +390512149072
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.
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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.
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Evaluating long-term outcomes in adults with congenital heart disease
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.
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.