An observational study in Congenital Heart Disease, Heart Failure and Transplant; Complication, Failure, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
The ARTORIA-R is an international, observational research project collecting retrospective data from 18 countries in the period 1989 to 2024 and will thereafter include data prospectively (Figure 1). These data include patient profiles at time of evaluation for listing, listing, waiting list dynamics, post-transplant data and basic donor data. Future data will be updated annually in July each year and each institution willing to contribute anonymised data to the register is invited to participate. Furthermore, the institutions and organ allocation agencies have to obtain a positive vote of the ethic committee responsible for the data transmission of anonymized patient data.
The inclusion criteria are: a. The patient has to be listed as an adult transplant candidate in the country the data is obtained with an age ≥18 years b. 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 c. Data is obtained from the first evaluation for listing or listing for heart-only or heart-combined organ transplantation d. Transfer of anonymised data e. The institution/organization agrees to the memorandum how data is managed, and scientific cooperation is planned between all institutions. The registry has the aim to achieve meticulous information regarding the underlying congenital heart defect and the previous treatment of the patient. With these information the patients can be divided into different cohorts with a systemic left ventricle, a systemic right ventricle or a single ventricle (which can be either an anatomic left or right ventricle). Further data is acquired regarding the medical treatment, the haemodynamic evaluation of the patient, laboratory testing to assess additional organ function of the kidney or liver, treatment in the intermediate care or intensive care unit. As it is of special relevance in ACHD patient treatment of arrhythmia, antiarrhythmic medication and use of ICD or cardiac resynchronization therapy are evaluated. Were available the data regarding imaging at listing with ejection fraction for the systemic ventricle with echocardiography or cardiac magnetic resonance imaging are obtained.
The exclusion criteria is: a. The patient is listed for a second heart transplantation (retransplantation) During the ongoing study additional institutions and organizations will be asked to include their data as well. Although the initial data is retrospective additional data into the register will be entered prospectively.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The PAtients pResenTing with COngenital HeaRt DIseAse Register (ARTORIA-R) will collect data from patients with ACHD evaluated or listed for heart or heart-combined organ transplantation from 19 countries in Europe and the Asia/Pacific region. We plan retrospective collection of data from 1989 - 2024 and will include patients prospectively. The primary outcome is the combined endpoint of delisting due to clinical worsening or death on the waiting list. The secondary outcome is delisting due to clinical improvement while on the waiting list.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
a. The patient is listed for a second heart transplantation (retransplantation)
Patients successfully transplanted due to congenital heart failure.
Patients on the actual waiting list for heart or heart and combined organ transplantation. They can have either outcome transplantation or the primary outcome death on the waiting list or delisting due to clinical worsening. The secondary outcome is as well delisting due to clinical improvement.
All patients evaluated for heart or heart and combined organ transplantation at the hospital level
Delisting due to clinical worsening or death on the waiting list
Patients who experience clinical worsening due to advanced heart failure may be removed from the waiting list. Patients may also die while on the waiting list.
Time frame: From the date of listing until delisting due to clinical worsening, death on the waiting list, transplantation, or last available follow-up, assessed up to 15 years.
Delisting due to clinical improvement
Patients may improve after listing and be removed from the waiting list because they no longer fulfill the criteria for heart or combined organ transplantation.
Time frame: From the date of listing until the date of delisting due to clinical improvement, transplantation, death, or last available follow-up, whichever occurs first, assessed up to 15 years.
All-cause mortality following transplantation
Patients who undergo successful transplantation are followed at the transplant center, and vital status is recorded during follow-up.
Time frame: From the date of transplantation until the date of death from any cause or last available follow-up, whichever occurs first, assessed up to 15 years after transplantation.
Implantation of a ventricular assist device as a bridge to transplantation, bridge to candidacy, or destination therapy
Some patients will receive a ventricular assist device as a bridge to transplantation or candidacy; others may receive the device as destination therapy.
Time frame: From the date of registry inclusion until the date of ventricular assist device implantation or last available follow-up, whichever occurs first, assessed up to 15 years.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data is shared with investigators participating in the register and provide patient data to the register
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data will be analysed at the University Heart and Vascular Center Hamburg. Researchers who did submit data to the registry are eligible to send as well a research proposal utilizing the whole data base. All statistical calculations will be done at the Department of Statistics of the Heart Center in Hamburg
Access criteria: Researchers entering data into the registry will do so using REDCap and will see only patients of the own center.
Started Sep 2020 (actual). Primary completion is estimated for Jul 2030, 118 months after the start.
Of 178 non-industry observational studies under Heart Defects, Congenital, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 83. This study's planned 118 months is above that.
Counting every sponsor, half of 185 studies reached it within 44 months; a quarter within 17 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
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