A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy

Running, not enrolling · Not applicable

Conditions studied: Heart Transplant Failure and Rejection

In brief

This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. EMB during this phase is expected to occur roughly weekly or bi-weekly. Study group assignment will take place at randomization. Subjects will be randomized 30 days (± 10 days) post-transplant to Prospera surveillance versus EMB surveillance in a 2:1 ratio. Rejection surveillance (Prospera Group and EMB Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance.

Key facts

Study ID

NCT06414603

Run by

Natera, Inc.

People needed

250

Starts

2024-06-10

Expected to finish

2027-02-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older at the time of signing informed consent.
• Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant.
• Able to read, understand and provide written informed consent. If the patient is unable to sign informed consent, a legally authorized representative (LAR) can consent on behalf of the patient.
• Able and willing to comply with the study visit schedule, study procedures and study requirements.

You may not qualify if…

• Concurrent multiple solid organ or tissue transplants.
• Prior history of any organ or cellular transplantation.
• Planned use of other commercially available or investigational cfDNA or gene expression profile assays for rejection surveillance.
• Pregnant.
• Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• University of Colorado — Aurora, Colorado, United States
• Mayo Clinic — Jacksonville, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• NYU Langone Health — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas, Southwestern Medical Center — Dallas, Texas, United States
• Baylor Scott White - Temple — Temple, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Inova Schar Heart and Vascular Institute — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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