Surveillance HeartCare® Outcomes Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Surveillance HeartCare® Outcomes Registry

Conditions
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Heart Transplant Rejection

Intervention / Treatment
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* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1. Patients who are pregnant at the time of blood draw.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HeartCare<br>Diagnostic Test: Heart Care 2300 patients managed with HeartCare (AlloMap® and AlloSure-Heart® ) | Other: Standard of Care<br>* Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody<br>|
| Control<br>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. | Other: Standard of Care<br>* Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant. | 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. | Dec-2026 |