Comparing two methods for monitoring heart transplant rejection

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

This study is testing whether a new blood test using cell-free DNA can better monitor heart transplant rejection compared to the traditional tissue biopsy method for heart transplant patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Natera, Inc. (Industry-sponsored)
• Locations: 11 sites (Los Angeles, California and 10 other locations)
• Trial ID: NCT06414603 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of using cell-free DNA (cfDNA) testing compared to traditional endomyocardial biopsy (EMB) for monitoring rejection in heart transplant patients. Participants will be randomly assigned to either the Prospera cfDNA surveillance group or the EMB surveillance group after their heart transplant. Both groups will undergo standard care assessments and complete quality of life questionnaires at specified intervals post-transplant. The study aims to determine which method provides better outcomes in terms of rejection detection and patient quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are undergoing evaluation for heart transplantation or are on the transplant waiting list.

Not a fit: Patients with concurrent multiple organ transplants or those who have had prior organ transplants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a less invasive and more effective method for monitoring heart transplant rejection, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using cfDNA for rejection surveillance, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years or older at the time of signing informed consent.
2. Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant.
3. 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.
4. Able and willing to comply with the study visit schedule, study procedures and study requirements.

Exclusion Criteria:

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

Where this trial is running

Los Angeles, California and 10 other locations

• Cedars-Sinai Medical Center — Los Angeles, California, United States (Not_yet_recruiting)
• University of California, San Diego — San Diego, California, United States (Recruiting)
• University of Colorado — Aurora, Colorado, United States (Recruiting)
• Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
• Piedmont Healthcare — Atlanta, Georgia, United States (Not_yet_recruiting)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• University of Texas, Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
• University of Utah — Salt Lake City, Utah, United States (Recruiting)
• Inova Schar Heart and Vascular Institute — Falls Church, Virginia, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Kiara Stoddard

Conditions Heart Transplant Failure and Rejection; Heart Transplant