Pharmacology of Immunosuppressants Following Heart Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University Hospital Birmingham.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Nigel E. Drury, University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT01423552
First received: August 23, 2011
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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.


Condition
Heart Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Immunosuppressant Pharmacokinetics, Pharmacodynamics, Pharmacogenomics and Outcomes Following Heart Transplantation

Resource links provided by NLM:


Further study details as provided by University Hospital Birmingham:

Primary Outcome Measures:
  • Correlation of immunosuppressant drug levels in different compartments with evidence of rejection [ Time Frame: Multiple timepoints in first 12 months after transplantation ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

Myocardial biopsy, whole blood, peripheral lymphocytes


Estimated Enrollment: 100
Study Start Date: November 2011
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Heart transplantation at the Queen Elizabeth Hosptial Birmingham.

Criteria

Inclusion Criteria:

  • All patients undergoing heart transplantation

Exclusion Criteria:

  • Decline participation
  • Previous transplantation of another organ and already receiving chronic immunosuppressive therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423552

Contacts
Contact: Nigel E Drury, MRCS 01216272890 nigel.drury@uhb.nhs.uk

Locations
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         
United Kingdom
Queen Elizabeth Hospital Birmingham Not yet recruiting
Birmingham, West Midlands, United Kingdom, B15 2WB
Contact: Nigel E Drury, MRCS    01216272850    nigel.drury@uhb.nhs.uk   
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         
Sponsors and Collaborators
Nigel E. Drury
Investigators
Principal Investigator: Robert S Bonser, MD FRCS University Hospital Birmingham
  More Information

No publications provided

Responsible Party: Nigel E. Drury, Specialist Registrar & Honorary Clinical Lecturer, University Hospital Birmingham
ClinicalTrials.gov Identifier: NCT01423552     History of Changes
Other Study ID Numbers: RRK4220
Study First Received: August 23, 2011
Last Updated: August 25, 2011
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University Hospital Birmingham:
Heart transplantation
Immunosuppression
Pharmacokinetics
Pharmacogenetics

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014