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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.


Clinical Trial Description

n/a


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01423552
Study type Observational
Source University Hospital Birmingham
Contact Nigel E Drury, MRCS
Phone 01216272890
Email nigel.drury@uhb.nhs.uk
Status Not yet recruiting
Phase N/A
Start date November 2011

See also
  Status Clinical Trial Phase
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Recruiting NCT01705015 - Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement N/A
Completed NCT01655563 - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation Phase 2
Completed NCT01028599 - Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients N/A
Completed NCT00531921 - Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival N/A
Terminated NCT00420537 - Shift to Everolimus (RAD) Kidney Sparing Study Phase 4
Enrolling by invitation NCT03292861 - The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients Phase 2
Recruiting NCT04924491 - Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children Phase 1/Phase 2
Recruiting NCT05270902 - Haemoadsorption During Heart Transplantation N/A
Completed NCT05289180 - Brachial Right Ventricle - Endomyocardial Biopsy
Recruiting NCT03687723 - Observational Study of the Clinical Use of the OCS™ Heart
Completed NCT01091194 - Effect of Exercise After Heart Transplantation Phase 2
Withdrawn NCT00780637 - Brachial Artery t-PA Release in Heart Transplant Recipients N/A
Terminated NCT00678002 - Quality of Life in Pediatric Transplant Patients
Completed NCT01182571 - Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients N/A
Withdrawn NCT00780377 - Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients N/A
Withdrawn NCT00572286 - Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study N/A
Terminated NCT00121784 - Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients Phase 4
Completed NCT00123331 - Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation Phase 4