Clinical trial NCT01423552: Pharmacology of Immunosuppressants Following Heart Transplantation
Official title: Correlation of Immunosuppressant Pharmacokinetics, Pharmacodynamics, Pharmacogenomics and Outcomes Following Heart Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Transplantation
Keywords: Heart transplantation
Immunosuppression
Pharmacokinetics
Pharmacogenetics
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart transplantation at the Queen Elizabeth Hosptial Birmingham.

Brief summary: The ongoing success of transplantation is largely due to the development of drugs to stop the patient's body from rejecting the new organ. In addition to steroids, two main types of drug are used to suppress the immune system following heart transplantation: calcineurin inhibitors (Ciclosporin-A or Tacrolimus) and mycophenolate. However, different patients respond in different ways to these drugs, with the same dose leading to different levels of the drug in the blood. This varies due to genetic and other factors such as age, kidney function and the use of other drugs. Therefore, the levels of immunosuppressive drugs in the blood are routinely measured and the dose adjusted accordingly. However, some patients still experience episodes of rejection despite apparently acceptable levels. In this study, the investigators will measure levels of the drugs (in the blood, in a type of white blood cell called T-cells and in the heart muscle) and the effectiveness of the drugs on T-cells. The investigators will compare these levels with patient genetic factors and the amount of rejection measured on heart biopsies. This will enable us to better understand how the blood and tissue levels of these drugs change with genetic and other factors in order to optimise immunosuppressive therapy and further improve outcomes from heart transplantation.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing heart transplantation

Exclusion Criteria:

* Decline participation
* Previous transplantation of another organ and already receiving chronic immunosuppressive therapy

Primary outcomes:
measure: Correlation of immunosuppressant drug levels in different compartments with evidence of rejection
timeFrame: Multiple timepoints in first 12 months after transplantation
Secondary outcomes:
measure: Correlation of individual patient genetic and other factors with levels of immunosuppressant drugs in different compartments
timeFrame: Multiple timepoints in first 12 months after transplantation
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Basil Hetzel Institute for Medical Research
state: South Australia
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: West Midlands
Study officials:
affiliation: University Hospital Birmingham
name: Robert S Bonser, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References: