Heart Transplant Rejection
Conditions
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.
Interventions
OTHERStandard of Care
Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody
Sponsors
CareDx
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKiran Khush, MD
Stanford University
Outcome results
None listed