Genomics in Heart Transplants

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf

About this trial

A cross-sectional analysis of 200 heart transplant recipients, combining in-depth phenotyping and risk factor assessment (cardiac MRI, coronary angiogram with OCT, cardiorespiratory exercise tests, exogenic factors like nutrition, smoking, lipid profile) with short-read whole-genome sequencing to elucidate the interplay of established PRS from the literature and exogenic risk factors with respect to HTx outcomes will be carried out.

Besides that, a long-read whole-genome sequencing of 100 newly transplanted recipients and their corresponding donors and extend latest bioinformatics methods developed by the study to analyze long-read data will be performed. This will enable a comprehensive and integrated analysis of structural variants, polygenic risk, high-penetrance variant genotypes, immunogenetic (major and minor histocompatibility), and individual lifestyle risk factors in a unique donor-recipient cohort, elucidating the extent of within-cohort variability and cross-correlations between the considered potential risk factors and an exploratory analysis of the utility of genetic risk scores in light of the study results will be carried out.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients > 18 years old undergoing heart transplantation in our centre

Disqualifiers

< 18 years

incapable of giving consent

Trial population

Patients undergoing heart transplantation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

rate of Clinically significant ischemia

defined by cardiac allograft vasculopathy (CAV) grade \>1 \& cardiac magnetic resonance imaging (cMRI)

Time frame
5 years

Secondary outcomes

1

cardiovascular death

cardiovascular event as primary cause of death

Time frame
5 years
2

myocardial infarction

Incidence of Type I or II myocardial infarction (assessed by CMR, electrocardiogram, laboratory parameters according to the 4th universal definition of myocardial infarction)

Time frame
5 years
3

Hospitalisation (w/o allograft rejection)

All-cause hospitalisation with exception of acute allograft rejection

Time frame
5 years
4

Cardiac allograft vasculopathy (macrocirculatory)

Incidence: Coronary angiogram (+/- optic coherence tomography (OCT))

Time frame
5 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: