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Pharmacology of Immunosuppressants Following Heart Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by University Hospital Birmingham.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Nigel E. Drury, University Hospital Birmingham Identifier:
First received: August 23, 2011
Last updated: August 25, 2011
Last verified: August 2011
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.

Heart Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Immunosuppressant Pharmacokinetics, Pharmacodynamics, Pharmacogenomics and Outcomes Following Heart Transplantation

Resource links provided by NLM:

Further study details as provided by University Hospital Birmingham:

Primary Outcome Measures:
  • Correlation of immunosuppressant drug levels in different compartments with evidence of rejection [ Time Frame: Multiple timepoints in first 12 months after transplantation ]
    We will compare the levels of the drugs in different compartments of the body (in the blood, within white blood cells and within the heart muscle itself) with how well the drugs are working ie. how well the heart is functioning and the level of rejection seen on routine heart biopsies. Drug levels will be measured at C0 (trough) and C2 (peak).

Secondary Outcome Measures:
  • Correlation of individual patient genetic and other factors with levels of immunosuppressant drugs in different compartments [ Time Frame: Multiple timepoints in first 12 months after transplantation ]
    We will also compare these results with patient genetic and other factors (eg. age, kidney function, use of other drugs) to better understand how these factors affect the levels of the drugs in different compartments of the body. Drug levels will be measured at C0 (trough) and C2 (peak).

Biospecimen Retention:   Samples With DNA
Myocardial biopsy, whole blood, peripheral lymphocytes

Estimated Enrollment: 100
Study Start Date: November 2011
Post-heart transplant
All patients undergoing heart transplantation at the Queen Elizabeth Hosptial Birmingham in the last 12 months or in the next year.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart transplantation at the Queen Elizabeth Hosptial Birmingham.

Inclusion Criteria:

  • All patients undergoing heart transplantation

Exclusion Criteria:

  • Decline participation
  • Previous transplantation of another organ and already receiving chronic immunosuppressive therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01423552

Australia, South Australia
Basil Hetzel Institute for Medical Research
Adelaide, South Australia, Australia
United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2WB
Sponsors and Collaborators
Nigel E. Drury
Principal Investigator: Robert S Bonser, MD FRCS University Hospital Birmingham
  More Information

Responsible Party: Nigel E. Drury, Specialist Registrar & Honorary Clinical Lecturer, University Hospital Birmingham Identifier: NCT01423552     History of Changes
Other Study ID Numbers: RRK4220 
Study First Received: August 23, 2011
Last Updated: August 25, 2011

Keywords provided by University Hospital Birmingham:
Heart transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on February 20, 2017