NCT00466804

Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients

Official Title:

Observational Study of Alloimmunity in Cardiac Transplant Recipients

Summary

Injury of transplant tissue by a transplant recipient's immune system continues to be the leading cause of graft rejection and recipient death. The purpose of this study is to identify a single test or a combination of noninvasive tests currently used for heart transplant monitoring that correlate to long-term graft survival.

Eligibility

Inclusion Criteria:

* Age greater than 10 and a body mass of 30 kg (66 lbs) or more
* On waiting list for a heart transplant for whom a donor heart available
* Willing to comply with study protocol
* Willing to use acceptable forms of contraception
* Parent or guardian willing to provide consent, if applicable

Exclusion Criteria:

* Receiving multiple organ transplants
* Previously received organ transplants
* Other comorbidities that, in the opinion of the site investigator, would interfere with the study
* Currently taking immunosuppression for nontransplant reasons
* Participation in an interventional clinical trial
* Pregnancy or breastfeeding

Disease(s) and\or Condition(s)

Heart Transplant

Primary Purpose
Intervention/Treatment
    • Type: PROCEDURE
    • Name: Heart transplant
    • Description: People in this study will have a heart transplant and be monitored for signs of rejection
    • Arm Group Labels: Heart Transplant Recipients
Sponsor
  • National Institute of Allergy and Infectious Diseases (NIAID)