Quantitative Detection of Circulating Donor-Specific DNA in Organ Transplant Recipients (DTRT-Multi-Center Study)

Completed

Conditions studied: Cardiovascular Disease, Acute Rejection of Cardiac Transplant, Cardiac Transplant Rejection, Heart Transplant Failure and Rejection

In brief

The primary goal of this Multicenter Study is to develop and to evaluate a method for measuring donor-specific cell free DNA in blood samples from transplant recipients as markers of rejection. Blood samples obtained periodically from heart transplant recipients are assessed for cell free DNA relative to clinical data in order to determine whether changes in the level of cell free DNA indicate rejection. This research study proposes testing a blood sample obtained from the heart transplant recipient. The research seeks to establish whether this blood test will show when the patient is beginning to or already rejecting the transplanted heart. BACKGROUND Identifying if a transplant patient is beginning to or already rejecting the heart is necessary, so that appropriate treatment can be started to halt the rejection. Heart catheterization with biopsy is the usual method used for assessing whether a patient may be rejecting the heart. There are also a number of other methods that transplant physicians will use to look for signs of rejection including other blood tests, echocardiograms, obtaining pressure readings during heart catheterization, and micro-array testing of blood obtained during biopsy. These technologies are limited in ability to consistently and accurately identify the presence of rejection. The usual method of checking for rejection involves obtaining a sample of the heart tissue (heart biopsy); biopsy can only be accomplished through heart catheterization which is an invasive procedure that has risks associated with disturbing the heart such as puncturing the heart or causing the heart rate to change or damaging tissue in the heart. Overtime, repeating this invasive procedure can diminish the ease of the procedure because the veins can become scarred and more difficult to access. For these reasons, researchers believe that it would be good to have a blood test that gives information about the possibility of rejection so that it may not be necessary to do as many heart biopsies. Also, a blood test may be able to provide information about the heart or about rejection that is currently not available at all.

Key facts

Study ID

NCT02109575

Run by

Medical College of Wisconsin

People needed

540

Starts

2014-03-01

Expected to finish

2020-03-30

Last updated by the study team

2021-03-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient who is "listed" to undergo or has in the past undergone heart transplantation.

You may not qualify if…

• Any patient who is not currently listed to undergo heart transplantation or has not previously received a heart transplant;
• Any patient who is not anticipated to be available for follow-up of at least 1 year;
• Any patient who is unable or unwilling to provide documented informed consent for self or through a legally authorized representative.

Where it is running

• Arkansas Children's Hosoptial Research Institute — Little Rock, Arkansas, United States
• Emory University — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital Chicago — Chicago, Illinois, United States
• Columbia University — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• Froedtert Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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