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

What is the Purpose of this Study?

This study focuses on adults who are undergoing heart transplant evaluation or are on the waiting list and expected to receive a heart transplant. The purpose of the study is to determine whether an investigational blood test called Prospera (also known as cell-free DNA testing) can be used in patient care instead of heart biopsy. Researchers aim to describe the association between Prospera and other procedures used to detect heart transplant rejection and/or injury in the first year after transplant. Study procedures include blood draws and data collection from MRIs and echocardiograms. Sometimes, a transplanted heart is rejected by the body. To detect rejection, doctors may order blood or imaging tests or perform a heart biopsy. Prospera is used to aid detection of risk for allograft rejection by finding DNA from the transplanted organ in the blood. When there is an increase in DNA from the donor heart in the patient’s blood, there may be a higher chance of rejection.


Eligibility

  • 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.
  • 4. Able and willing to comply with the study visit schedule, study procedures, and study requirements.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

DevelopmEnt of non-invasive cell-Free DNA to supplant INvasivE biopsy in Heart Transplantation

Study Details
Disease Type/Condition

Heart transplant candidates

Principal Investigator

Kransdorf, Evan

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002431

ClinicalTrials.gov ID

NCT05309382

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Heart transplant candidates

Principal Investigator

Kransdorf, Evan

Age Group

Adult

Phase

N/A

IRB Number

22-062-TRP

ClinicalTrials.gov ID

NCT05309382

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org