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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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
nigel.drury@uhb.nhs.uk
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01423552