Recruiting

Observational Study

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT02423070

Conditions

Thoracic Organ Transplantation

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Thoracic Organ Transplantation

Study ID

NCT02423070

Start date

Jun 25, 2015

Status verified date

Sep 17, 2026

Completion date

Nov 30, 2034

Anticipated

Primary completion date

Nov 30, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

991 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Heart and Lung Transplant patients

Primary outcome measure

  • To validate the predictive accuracy and ROC characteristics of circulating cell- free donor derived DNA (cfDNA) in multicenter, prospective cohort study of heart and lung transplant patients, recruited through a consortium of 5 transplant center... [ Time Frame: At the time of biopsy-proven rejection ]

Central Contacts and Locations

Central contacts

Sean T Agbor-Enoh, M.D.

(703) 677-4630agborenohst@mail.nih.gov

Locations

Dignity Health St. Joseph's Hospital and Medical Center Norton Thoracic Institut

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Sofya Tokman, M.D.

602-406-4000sofya.tokman@commonspirit.org

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Steven Hsu

410-955-3468steven.hsu@jhmi.edu

Pali Shah

(410) 955-3468pdedhiy2@jhmi.edu

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

INOVA Fairfax Medical

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Palak Shah, M.D.

703-776-2213palak.shah@inova.org

Steven Nathan, M.D.

(703) 776-2213steven.nathan@inova.org

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Oct 13, 2026

Last verified

Sep 17, 2026

Keywords

  • Cell-free DNA
  • Acute Rejection
  • Thoracic Organ Transplantation
  • Non-Invasive Testing
  • Chronic Rejection
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.