Detection of Transplanted Heart Rejection by Blood Cell Gene Expression: a Novel Concept of Personalized Approach to Heart Transplantation Management

Detection of Cardiac Allograft Rejection by Peripheral Blood Gene Expression in Paediatric Cardiac Transplant Patients

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000008921

Enrollment

Registered

2011-01-05

Start date

2011-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Rejection of a transplanted heart is a serious and often fatal complication following heart transplantation. Endomyocardial biopsy is the gold standard for diagnosing heart transplant rejection. Transplanted patients undergo 9 endomyocardial biopsies for routine surveillance in the first 12 months after transplant. We know that immune cells in peripheral blood become activated during rejection. They change their gene expression and this can be detected by specific biochemical tests called microarrays. As such, it is our belief that rejection of a transplanted heart may be detected by taking a peripheral blood sample and looking at the gene expression of immune cells. The implication is that transplant rejection may be detected by simply taking blood rather than performing an endomyocardial biospy. An endomyocardial biospy is an invasive procedure performed under general anaesthesia and is therefore stressful for patients and patients' parents as well as placing a sizeable on the healthcare system. Our project will involve taking a small 5ml venous blood sample from patients immediately prior to heart transplantation and all subsequent endomyocardial biopsies for routine surveillance. The blood samples will be taken after induction of general anaesthesia. We will then be able to compare each result of the microarray of the blood sample with the result of the endomyocardial biopsy in order to assess whether peripheral blood sampling is a possible alternative to endomyocardial biospy.

Interventions

The study will be performed on 10 consecutive children undergoing heart transplantation. The venous blood sample (5 ml each) will be taken immediately after induction of anaesthesia prior to heart transplantation and then immediately after induction of anaesthesia prior to each regular routine endomyocardial biopsy during 1st year after transplantation (9 biopsies). Thus, this equates to a total of 10 samples per patient. Change in blood genomic profile is compared longtitudinally and compared w

Eligibility

Sex/Gender

All

Age

5 Years to 18 Years

Healthy volunteers

Inclusion criteria

10 consecutive children aged 5-18 years undergoing heart transplantation and follow up clinical management at the Royal Children's Hospital, Melbourne.

Exclusion criteria

Cardiac transplantation under age 5 and non-cardiac transplantation.

Outcome results