Development of Non-invasive Cell-free DNA to Supplant Invasive Biopsy in Heart Transplantation

Overview

About this study

The purpose of this study is to describe the association between Prospera dd-cfDNA measures and other diagnostic tests used to detect heart allograft rejection and/or njury, including histology, echocardiography and DSA, in the first post-transplant year. Additionally, to inform rates of clinical outcomes in a contemporary cohort of adult heart transplant recipients to determine power for a future randomized, controlled clinical trial.

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.
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.
Pregnant.

Eligibility last updated 7/8/22. 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.	Closed for enrollment	Contact information: Erika Swint (904) 953-2723 Swint.Erika@mayo.edu

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jose Nativi Nicolau, M.D.

Closed for enrollment

Contact information:

Erika Swint

(904) 953-2723

Swint.Erika@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials