NCT03695601

Surveillance HeartCare® Outcomes Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,743 (estimated)
• Sponsor: CareDx · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Transplant Rejection

Interventions

Type	Name	Description
OTHER	Standard of Care	Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody

Timeline

• Start date: 2018-12-28
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2018-10-04
• Last updated: 2026-02-23

Locations

67 sites across 1 country: United States