Pharmacology of Immunosuppressants Following Heart Transplantation

NCT ID: NCT01423552

Last Updated: 2011-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-heart transplant

All patients undergoing heart transplantation at the Queen Elizabeth Hosptial Birmingham in the last 12 months or in the next year.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing heart transplantation

Exclusion Criteria

* Decline participation
* Previous transplantation of another organ and already receiving chronic immunosuppressive therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nigel E. Drury

OTHER

Sponsor Role lead

Responsible Party

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Nigel E. Drury

Specialist Registrar & Honorary Clinical Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert S Bonser, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

University Hospital Birmingham

Locations

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Basil Hetzel Institute for Medical Research

Adelaide, South Australia, Australia

Site Status

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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Australia United Kingdom

Central Contacts

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Nigel E Drury, MRCS

Role: CONTACT

01216272890

Facility Contacts

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Benedetta C Sallustio, PhD

Role: primary

Nigel E Drury, MRCS

Role: primary

01216272850

Other Identifiers

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RRK4220

Identifier Type: -

Identifier Source: org_study_id

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