Registry for adults with congenital heart disease and heart transplantation
The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R): A Global Register to Investigate Factors Associated With Morbidity and Mortality in Adult Patients With Congenital Heart Disease (ACHD) on the Waiting List for Heart or Heart/Lung Transplantation
This study is collecting information about adults with congenital heart disease who may need a heart transplant to better understand their experiences and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT04848844 on ClinicalTrials.gov |
What this trial studies
The ARTORIA-R project is an international observational registry that collects both retrospective and prospective data on adults with congenital heart disease (ACHD) who are candidates for heart transplantation. It aims to gather comprehensive information on patient profiles, listing dynamics, and post-transplant outcomes across 18 countries from 1989 to 2024. Institutions are invited to contribute anonymized data, ensuring ethical compliance and scientific collaboration. The registry seeks to enhance understanding of the complexities and outcomes associated with ACHD and heart failure.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older who are listed as transplant candidates with congenital heart defects or inherited cardiomyopathies.
Not a fit: Patients who are listed for a second heart transplantation will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could improve patient outcomes by providing valuable insights into the management and treatment of adults with congenital heart disease.
How similar studies have performed: Other similar registries have shown success in improving patient care and outcomes in congenital heart disease, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The patient has to be listed as an adult transplant candidate in the country the data is obtained with an age ≥18 years 2. The patient has to have a congenital heart defect or an inherited cardiomyopathy (specific; hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy or non-compaction cardiomyopathy) which is often included into the category ACHD 3. Data is obtained from the first evaluation for listing or listing for heart-only or heart-combined organ transplantation 4. Transfer of anonymised data 5. The institution/organization agrees to the memorandum how data is managed, and scientific cooperation is planned between all institutions Exclusion Criteria: a. The patient is listed for a second heart transplantation (retransplantation)
Where this trial is running
Hamburg
- University Heart and Vascular Center Hamburg — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Christoph Sinning, MF — University Heart & Vascular Center Hamburg
- Study coordinator: Christoph Sinning, MD
- Email: c.sinning@uke.de
- Phone: 004915222817675
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.