Pharmacology of Immunosuppressants Following Heart Transplantation

• Conditions: Heart Transplantation

• Registration Number: NCT01423552
• Lead Sponsor: Nigel E. Drury

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-25
• Last Update Submitted: 2011-08-25
• Study First Posted: 2011-08-26
• Last Update Posted: 2011-08-26
• Study Start: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients undergoing heart transplantation

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of immunosuppressant drug levels in different compartments with evidence of rejection	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

Name	Time	Method
Correlation of individual patient genetic and other factors with levels of immunosuppressant drugs in different compartments	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).

Trial Locations

Locations (2)

Basil Hetzel Institute for Medical Research; 🇦🇺 Adelaide, South Australia, Australia

Queen Elizabeth Hospital Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom