The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)

ConditionsCongenital Heart Disease Heart Failure Transplant; Complication, Failure Arrythmia Ventricular Dysfunction

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants

are grouped into 3 trial groups

Group A: Patient transplanted due to ACHD and heart failure

Group B: ACHD listed due to heart failure for heart or heart and combined organ transplantation

Group C: ACHD evaluated for heart transplantation

Trial outcomes

Primary outcomes

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.

Secondary outcomes

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.

Other outcomes

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitätsklinikum Hamburg-Eppendorf

Lead sponsor

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Collaborator

Source ClinicalTrials.gov

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