Summary

Eligibility
for people ages 15 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Teresa DeMarco, MD
Photo of Teresa DeMarco
Teresa DeMarco

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. Heart transplant recipients who are selected by their health care provider to be managed with HeartCare.
  3. Patients who are selected by their health care provider to be managed following the Heart Routine Testing Schedule (HARTS) or a derivative of the schedule that has been defined by the provider.
  4. Patients who provide written informed consent.
  5. Patients who have HeartCare initiated within 30 days of signing the informed consent form.

You CAN'T join if...

  1. Patients who are less than 15 years of age at the time of blood draw.
  2. Heart transplant recipients who are not managed with HeartCare.
  3. Patients who are not managed following the Heart Routine Testing Schedule (HARTS) or a derivative of the schedule that has been defined by the provider.
  4. Patients who are pregnant at the time of blood draw.
  5. Patients who do not provide written informed consent.

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • California Pacific Medical Center accepting new patients
    San Francisco California 94115 United States

Lead Scientist at UCSF

  • Teresa DeMarco, MD
    CLINICAL INTERESTS: Advanced heart failure, cardiomyopathies, heart transplantation, mechanical circulatory support, and pulmonary hypertension RESEARCH INTERESTS: Translational research in the diagnosis, prognosis, medical and surgical treatment for the above disease states

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CareDx
ID
NCT03695601
Study Type
Observational
Last Updated