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.

Age: 15 Years and older

Gender: All

Start Date: 12/28/2018

Primary Completion Date (Estimated): 11/01/2026

Study Completion Date (Estimated): 11/01/2026

Accepts Healthy Volunteers: No

Trial Purpose and Description

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.

Eligibility Criteria

Age: 15 Years and older

Gender: All

Accepts Healthy Volunteers: No

Inclusion criteria:

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

Exclusion criteria:

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