RecruitingNCT02423070

Genome Transplant Dynamics


Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Enrollment

991 participants

Start Date

Jun 25, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

Study Description: Heart and lung transplants can save lives, but long-term success is often limited by organ rejection that is hard to detect early. This study is testing a new, non-invasive blood test that looks for small pieces of DNA from the donor organ in the patient s blood. We believe higher levels of this donor DNA may signal early rejection before damage becomes permanent. Hypothesis: We believe that measuring donor-derived DNA in the blood can help detect early signs of rejection and improve outcomes for transplant patients. The study also collects genetic and biological samples to explore why some people are more at risk of complications after transplant. This may help guide future research and treatments. Who Can Join the Study: People receiving a heart or lung transplant (or both), age 14 and older People who are within three months of their transplant People who can understand and agree to take part in the study Participants will be asked to provide blood and other samples, and some of these will be used in lab research to explore new ideas about how and why transplant rejection happens. This research could lead to better ways to monitor and treat patients after a heart or lung transplant - and help improve long-term survival and quality of life.


Eligibility

Min Age: 14 YearsMax Age: 80 Years

Inclusion Criteria5

  • Lung and heart transplant candidates. Dual organ transplants such as those that include lung or heart PLUS any other organ are also considered for enrollment.
  • Subjects who have undergone lung or heart transplants and are within 3 months of transplantation.
  • years and older
  • Able to understand and be willing to sign the informed consent form. Subjects undergoing a double transplant will sign a single consent.
  • Retransplant candidates will be considered as a new transplants. These subjects will be approached for enrollment and if they consent to participate, they will be assigned a different SSPIN.

Exclusion Criteria1

  • Pregnancy

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Locations(6)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of Maryland

Baltimore, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

INOVA Fairfax Medical

Falls Church, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT02423070