The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R) (NCT04848844) | Clinical Trial Compass
RecruitingNot Applicable
The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)
Germany2,000 participantsStarted 2020-09-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a registry study called ARTORIA-R that tracks adults with congenital heart disease who are being evaluated for a heart transplant — is my situation a good fit for a study like this, and what would actually be involved in participating?
2Since this is a registry rather than a treatment trial, it's collecting data on outcomes like dying or getting too sick to stay on the transplant waiting list — how might being part of this registry affect my own care, if at all?
3The study is measuring how often patients are removed from the transplant waiting list due to worsening condition or death — what does that tell us about the real risks I face while waiting, and how does my doctor think my condition compares to others in that situation?
4Because this is a data-collection study with no assigned treatment, would joining it change anything about the standard care or transplant evaluation process I'd otherwise go through?
5Are there other registries or treatment trials for adults with congenital heart disease and heart failure that my doctor thinks I should also consider alongside or instead of this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Delisting due to clinical worsening or death on the waiting list
Timeframe: 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.