Surveillance HeartCare® Outcomes Registry
- Conditions
- Heart Transplant Rejection
- Registration Number
- NCT03695601
- Lead Sponsor
- CareDx
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2743
- Patients who are 15 years of age or older at the time of blood draw.
- Received a heart transplant (primary or repeat)
- Patients who have HeartCare initiated within 3 months post-transplant
1. Patients who are pregnant at the time of blood draw.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant. Dec-2026 The primary endpoint of the study is the proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant. The overall incidence of de-novo DSA is between 10-20% in the first year and 10-15% each year subsequently.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (67)
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Baptist Health Arkansas
🇺🇸Little Rock, Arkansas, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of California San Fransisco Medical Center
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
Yale New Haven
🇺🇸New Haven, Connecticut, United States
Scroll for more (57 remaining)Mayo Clinic Arizona🇺🇸Phoenix, Arizona, United States