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

Overview

About this study

The purpose of this study is to compare the effectiveness of rejection surveillance of heart transplant recipients with Prospera dd-cfDNA to rejection surveillance with endomyocardial biopsy (EMB) in the first post-transplant year.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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 the 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.

Exclusion Criteria:

  • 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/13/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jose Nativi Nicolau, M.D.

Open for enrollment

Contact information:

Nicolas Dybel

(904) 953-4324

Dybel.Nicolas@mayo.edu

More information

Publications

Publications are currently not available