A Study to Analyze Tacrolimus Metabolism in Heart Transplant Patients

Overview

About this study

The puprose of this study is to evaluate pharmacogenomic differences of CYP 3A5 in heart transplant patients, to determine dose ranges and pharmacodynamics properties of tacrolimus metabolism based on CYP 3A5 genotype/phenotype combinations, and to assess whether CYP3A5 polymorphism influences post-transplant outcomes including survival, rejection and infection rates.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults, aged 18 to 99 years old.
  • All heart-only transplant patients either currently listed or transplated.
  • Patients taking tacrolimus as sole calcineurin therapy.

Exclusion Criteria:

  • Multiple organ transplant patients.
  • Patients taking more than one calcineurin agent.
  • Patients previously on sirolimus (rapamune) and now on tacrolimus.
  • Those patients with any history of heart disease irrespective of etiology.
  • Patients transplanted at non-Mayo Clinic centers.
  • Patients with a history of congenital heart disease.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Rohan Goswami, M.D.

Contact us for the latest status

Contact information:

Katelyn Register M.S., C.C.R.C.

Register.Katelyn@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20477449

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