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Search / Trial NCT02423070

Genome Transplant Dynamics

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Apr 18, 2015

Trial Information

Current as of July 04, 2025

Recruiting

Keywords

Cell Free Dna Acute Rejection Thoracic Organ Transplantation Non Invasive Testing Chronic Rejection Natural History

ClinConnect Summary

The Genome Transplant Dynamics clinical trial is studying a new blood test that could help doctors determine if a transplanted heart or lung is being rejected by the body. Currently, when patients receive these transplants, they often need painful and costly biopsies to check for rejection. This trial aims to see if measuring the amount of donor DNA in the blood can replace those biopsies, making it easier for patients to monitor their transplant health.

To participate, you need to be at least 14 years old and on the waiting list for a lung or heart transplant, or have had one within the last three months. If you join, you will have about four teaspoons of blood drawn before your transplant, and then two teaspoons drawn twice a week while you’re in the hospital. After you go home, you’ll continue to have blood drawn during follow-up visits for up to five years. This study is important because it could lead to less invasive testing for transplant patients, improving their care and comfort.

Gender

ALL

Eligibility criteria

  • * 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 National Heart, Lung, And Blood Institute (Nhlbi)

The National Heart, Lung, and Blood Institute (NHLBI) is a leading component of the National Institutes of Health (NIH), dedicated to advancing research and clinical trials focused on cardiovascular, pulmonary, and hematologic diseases. With a mission to improve public health through innovative research, the NHLBI supports a wide range of studies aimed at understanding, preventing, and treating heart and lung conditions. By collaborating with academic institutions, healthcare providers, and patient communities, the NHLBI strives to translate scientific discoveries into effective clinical practices, ultimately enhancing the quality of life for individuals affected by these critical health issues.

Locations

Bethesda, Maryland, United States

Baltimore, Maryland, United States

Washington, District Of Columbia, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Richmond, Virginia, United States

Falls Church, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Sean T Agbor-Enoh, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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