Observational study of adults with congenital heart disease
Observational Cohort Study of Adult Patients 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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06769529 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success in similar observational approaches, indicating the potential for valuable insights in managing congenital heart disease.
Eligibility criteria
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 this trial is running
Bologna
- 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
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.