Pharmacology of Immunosuppressants Following Heart Transplantation

NCT01423552 | Unknown

• 1 other identifier: RRK4220
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

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.

Conditions

Heart Transplantation

Keywords

Heart transplantation; Immunosuppression; Pharmacokinetics; Pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• Correlation of immunosuppressant drug levels in different compartments with evidence of rejection

  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).

  Multiple timepoints in first 12 months after transplantation

Secondary Outcomes (1)

• Correlation of individual patient genetic and other factors with levels of immunosuppressant drugs in different compartments

  Multiple timepoints in first 12 months after transplantation

Study Arms (1)

Post-heart transplant

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart transplantation at the Queen Elizabeth Hosptial Birmingham.

You may qualify if:

• All patients undergoing heart transplantation

You may not qualify if:

• Decline participation
• Previous transplantation of another organ and already receiving chronic immunosuppressive therapy

Sponsors & Collaborators

• Nigel E. Drury: lead

Study Sites (2)

Basil Hetzel Institute for Medical Research

Adelaide, South Australia, Australia

Location

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, B15 2WB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Myocardial biopsy, whole blood, peripheral lymphocytes

Study Officials

• Robert S Bonser, MD FRCS

  University Hospital Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nigel E Drury, MRCS

CONTACT

01216272890; nigel.drury@uhb.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Registrar & Honorary Clinical Lecturer

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 26, 2011
• Study Start: November 1, 2011
• Last Updated: August 26, 2011

Record last verified: 2011-08

Locations

GB (1); AU (1)