Surveillance HeartCare® Outcomes Registry (SHORE)

CareDx

Status: Active, not recruiting

Conditions: Heart Transplant Rejection

Treatments: Other: Standard of Care

Study type: Observational

Funder types: Industry

Identifiers

NCT03695601

SN-C-00011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,743 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,743 participants in 2 patient groups

HeartCare

Description:

Diagnostic Test: Heart Care 2300 patients managed with HeartCare (AlloMap® and AlloSure-Heart® )

Treatment:

Other: Standard of Care

Control

Description:

A historical control group will be matched to the estimated 1150 HeartCare group patients who complete at least two years of HeartCare surveillance use and inclusive of year 3 post-transplant clinical follow-up for outcome. The criteria for the matched controls will be based on allograft donor type, age, gender, ethnicity/race, and other clinical factors. Propensity scores will be used to perform the matching.

Treatment:

Other: Standard of Care