Pharmacology of Immunosuppressants Following Heart Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01423552|
Recruitment Status : Unknown
Verified August 2011 by Nigel E. Drury, University Hospital Birmingham.
Recruitment status was: Not yet recruiting
First Posted : August 26, 2011
Last Update Posted : August 26, 2011
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Correlation of Immunosuppressant Pharmacokinetics, Pharmacodynamics, Pharmacogenomics and Outcomes Following Heart Transplantation|
|Study Start Date :||November 2011|
All patients undergoing heart transplantation at the Queen Elizabeth Hosptial Birmingham in the last 12 months or in the next year.
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423552
|Contact: Nigel E Drury, MRCSemail@example.com|
|Australia, South Australia|
|Basil Hetzel Institute for Medical Research||Not yet recruiting|
|Adelaide, South Australia, Australia|
|Contact: Benedetta C Sallustio, PhD Benedetta.Sallustio@health.sa.gov.au|
|Principal Investigator: Benedetta C Sallustio, PhD|
|Queen Elizabeth Hospital Birmingham||Not yet recruiting|
|Birmingham, West Midlands, United Kingdom, B15 2WB|
|Contact: Nigel E Drury, MRCS 01216272850 firstname.lastname@example.org|
|Principal Investigator: Robert S Bonser, MD FRCS|
|Sub-Investigator: Nigel E Drury, MRCS|
|Sub-Investigator: Sern Lim, MD MRCP|
|Sub-Investigator: Majid Mukadam, FRCS|
|Sub-Investigator: Julie M Williams, PhD|
|Principal Investigator:||Robert S Bonser, MD FRCS||University Hospital Birmingham|