Status:

COMPLETED

Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Clinical Trials in Organ Transplantation

Conditions:

Heart Transplant

Eligibility:

All Genders

10+ years

Brief 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 o...

Detailed Description

A major cause of heart transplant failure is the blockage of blood flow from lesions caused by ongoing injury and repair of the graft by the host's immune system. However, the role of T cells, antibod...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 1 2011

Estimated Enrollment :

263 Patients enrolled

Trial Details

Trial ID

NCT00466804

Start Date

June 1 2007

End Date

July 1 2011

Last Update

January 1 2016

Active Locations (12)

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Page 1 of 3 (12 locations)

1

University of California

San Francisco, California, United States, 94143

2

Northwestern University Medical School

Chicago, Illinois, United States, 60611

3

Loyola University School of Medicine

Maywood, Illinois, United States, 60153

4

University of Maryland

Baltimore, Maryland, United States, 21201