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Sex Differences in SOT


Title Sex-based differences in immune response in solid organ transplant recipients
Therapeutic Area Kidney Transplantation, Heart Transplantation
Principal Investigator Whitney Perry, MD, MS
Min Age 18 Years
Gender All
Contact Whitney Perry
617-636-3594
wperry@tuftsmedicalcenter.org

Overview

This study is designed to find out whether there is a difference between how men and women respond to infections or vaccines following heart transplantation. We are recruiting men and women undergoing heart transplantation to participate by providing three blood samples over the course of about six months (taken in the same time and place as usual blood draws used for clinical purposes). We will use these samples to test levels of cells and proteins that are used fight infection and will compare these levels between male and female patients. In addition, we will gather information over the course of the first six post-transplant months about any infections or episodes of heart transplant rejection that you may experience. The point of the study is to identify if there could be different strategies used to prevent or treat infection in male versus female transplant recipients.

Study Details

Inclusion Criteria

  • Adult patients over the age of 18 (no upper age limit) who are undergoing heart transplant at TMC.
  • Planned follow-up care at TMC

Exclusion Criteria

  • Combined heart-kidney transplant recipients.
  • History of hematopoietic stem cell transplant (HSCT).
  • Inability to provide informed consent

Study Requirements

Each study participant will be asked to provide additional tubes of blood alongside their normal clinical labs at three different time-points (once before transplant, once one month after transplant, and once six months after transplant), each requiring a few minutes of time.

In addition to the above, a participant would be allowing members of the research team to check their chart in the electronic medical record to gather relevant data on demographics, chronic medical problems, prior vaccines or certain viral infections, occurrence of new infection or heart rejection, and transplant-related or hormone-related medications. These are items that are routinely recorded by clinical providers and no active participation is required from the study participant.