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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01423552




Registration number
NCT01423552
Ethics application status
Date submitted
23/08/2011
Date registered
26/08/2011
Date last updated
26/08/2011

Titles & IDs
Public title
Pharmacology of Immunosuppressants Following Heart Transplantation
Scientific title
Correlation of Immunosuppressant Pharmacokinetics, Pharmacodynamics, Pharmacogenomics and Outcomes Following Heart Transplantation
Secondary ID [1] 0 0
RRK4220
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Post-heart transplant - All patients undergoing heart transplantation at the Queen Elizabeth Hosptial Birmingham in the last 12 months or in the next year.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Correlation of immunosuppressant drug levels in different compartments with evidence of rejection
Timepoint [1] 0 0
Multiple timepoints in first 12 months after transplantation
Secondary outcome [1] 0 0
Correlation of individual patient genetic and other factors with levels of immunosuppressant drugs in different compartments
Timepoint [1] 0 0
Multiple timepoints in first 12 months after transplantation

Eligibility
Key inclusion criteria
- All patients undergoing heart transplantation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Decline participation

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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Basil Hetzel Institute for Medical Research - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Other
Name
Nigel E. Drury
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01423552
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert S Bonser, MD FRCS
Address 0 0
University Hospital Birmingham
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nigel E Drury, MRCS
Address 0 0
Country 0 0
Phone 0 0
01216272890
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01423552