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Genome Transplant Dynamics

Who can join

Ages 14 to 80 · All sexes

* INCLUSION CRITERIA:
* 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.
* 14 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 CRITERIA:

-Pregnancy

About the study

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.

Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · Participants: 991 · Started: Jun 25, 2015

Contact the study team

• Sean T Agbor-Enoh, M.D. · Phone: (703) 677-4630

Official record on ClinicalTrials.gov — NCT02423070

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.