NCT04848844Recruiting
The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
Advances in surgical and medical care have led to improved outcomes in patients with congenital heart disease (CHD). As a consequence, the majority of patients nowadays survives to adulthood (adults with CHD, that is, adult CHD \[ACHD\]) with good quality of life. Despite the surgical success, the morbidity and mortality of ACHD is higher than in the general population and is linked to the development of heart failure (HF) in adulthood. HF occurs in approximately 25% of patients with ACHD, even in those patients in whom the congenital mal-formation has been corrected successfully in childhood. The time course and presentation are heterogeneous owing to variable congenital malformation and limitation of treatment options. ACHD with an anatomic right ventricle as the systemic ventricle (e.g., atrial switch operation in patients with transposition of the great arteries \[TGAs\]) and those with a functional single ventricle (e.g., Fontan circulation) appear to be at higher risk of developing HF. Young age at initial corrective surgery-often in the first 2 years of life-and lack of specific medical therapies can contribute to a high and early demand for heart transplantation in patients with ACHD.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 7 Apr 2021
- Start date
- 2 Sept 2020
- Primary completion date
- 30 Jul 2030
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Diseases
- Heart failure
- NCT number
- NCT04848844
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 2 Sept 2020 to the primary completion date, 30 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- The patient is listed for a second heart transplantation (retransplantation)
Who the study is looking for
- The patient has to be listed as an adult transplant candidate in the country the data is obtained with an age ≥18 years
- 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
- Data is obtained from the first evaluation for listing or listing for heart-only or heart-combined organ transplantation
- Transfer of anonymised data
- The institution/organization agrees to the memorandum how data is managed, and scientific cooperation is planned between all institutions
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Heart and Vascular Center Hamburg Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.