Summary

Eligibility
for people ages 15 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.

Details

HeartCare is a service which includes AlloMap® and AlloSure-Heart® to provide information to help clinicians to more comprehensively monitor heart transplant recipients for allograft rejection. An approach to surveillance using HeartCare provides information from two complementary measures; AlloMap is a gene-expression profile based measure of host immune activity and risk of acute rejection. AlloSure-Heart monitors graft injury. AlloMap is the first FDA cleared test and is the only non-invasive, blood test method recommended in the International Society for Heart and Lung Transplantation (ISHLT) guidelines for surveillance of heart transplant recipients for rejection. AlloSure-Heart measures donor-derived cell-free DNA (dd-cfDNA) to help discriminate acute cellular rejection and antibody-mediated rejection from no rejection. Patients who receive HeartCare, as part of their post-transplant management, will give informed consent for information on their outcomes and other relevant clinical information, found in their medical records, to be entered into a SHORE database for purposes of the study.

Keywords

Heart Transplant Rejection, HeartCare

Eligibility

You can join if…

Open to people ages 15 years and up

  1. Patients who are 15 years of age or older at the time of blood draw.
  2. Received a heart transplant (primary or repeat)
  3. Patients who have HeartCare initiated within 3 months post-transplant

You CAN'T join if...

  1. Patients who are pregnant at the time of blood draw.

Locations

  • UC San Diego
    La Jolla California 92037 United States
  • University of California, Los Angeles
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CareDx
ID
NCT03695601
Study Type
Observational
Participants
Expecting 3450 study participants
Last Updated