Pharmacology of Immunosuppressants Following Heart Transplantation

Heart Transplantation Clinical Trial

Official title:

Correlation of Immunosuppressant Pharmacokinetics, Pharmacodynamics, Pharmacogenomics and Outcomes Following Heart Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01423552
• Other study ID #: RRK4220
• Status: Not yet recruiting
• Phase: N/A
• First received: August 23, 2011
• Last updated: August 25, 2011
• Start date: November 2011

Study information

• Verified date: August 2011
• Source: University Hospital Birmingham
• Contact: Nigel E Drury, MRCS
• Phone: 01216272890
• Email: nigel.drury[@]uhb.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing heart transplantation

Exclusion Criteria:

• Decline participation

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Transplantation

Locations

Country	Name	City	State
Australia	Basil Hetzel Institute for Medical Research	Adelaide	South Australia
United Kingdom	Queen Elizabeth Hospital Birmingham	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Nigel E. Drury

Countries where clinical trial is conducted

Australia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of immunosuppressant drug levels in different compartments with evidence of rejection	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).	Multiple timepoints in first 12 months after transplantation	No
Secondary	Correlation of individual patient genetic and other factors with levels of immunosuppressant drugs in different compartments	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).	Multiple timepoints in first 12 months after transplantation	No