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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
Other Locations
Germany
University Heart and Vascular Center Hamburg
RECRUITING
Hamburg
Contact Information
Primary
Christoph Sinning, MD
c.sinning@uke.de
004915222817675
Backup
Christina Magnussen, MD
c.magnussen@uke.de
Time Frame
Start Date: 2020-09-02
Estimated Completion Date: 2030-07-30
Participants
Target number of participants: 2000
Treatments
Patient transplanted due to ACHD and heart failure
Patients successfully transplanted due to congenital heart failure.
ACHD listed due to heart failure for heart or heart and combined organ transplantation
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.
ACHD evaluated for heart transplantation
All patients evaluated for heart or heart and combined organ transplantation at the hospital level
Sponsors
Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Leads: Universitätsklinikum Hamburg-Eppendorf

This content was sourced from clinicaltrials.gov