HeartCare Testing for Heart Transplant Rejection

(SHORE Trial)

Not currently recruiting at 82 trial locations

Overseen By Sham Dholakia

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: CareDx

Disqualifiers: Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial observes how well HeartCare testing services assist in managing care for individuals who have undergone a heart transplant. The goal is to determine the usefulness of these tests in monitoring the health of the new heart. Participants in this trial will be compared to a control group of similar transplant patients who receive standard care (also known as conventional or usual care) without using HeartCare. Suitable candidates are those who have recently had a heart transplant and started HeartCare testing within three months post-surgery. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in heart transplant care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that HeartCare testing services are safe for heart transplant recipients?

Research has shown that HeartCare testing services, including AlloMap and AlloSure-Heart, are safe and effective for monitoring heart transplant patients. These non-invasive tests do not require surgery or entering the body. In studies with over 2,000 participants, patients found these tests easy to handle. The FDA has approved AlloMap, a component of HeartCare, indicating it meets strict safety standards. Overall, HeartCare is designed to be safe and simple for patients, using easy blood tests instead of complicated procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HeartCare protocol because it offers a more personalized approach to monitoring heart transplant patients. Unlike traditional methods that rely heavily on invasive biopsies to assess heart health, HeartCare uses non-invasive diagnostic tests, AlloMap® and AlloSure-Heart®, to track and manage patient outcomes. These tests can potentially provide earlier and more accurate detection of rejection or complications, allowing for timely intervention and better long-term outcomes for patients. The use of these advanced diagnostic tools could revolutionize post-transplant care by making it less invasive and more precise.

What evidence suggests that HeartCare testing services are effective for heart transplant recipients?

Research has shown that HeartCare testing services, including AlloMap® and AlloSure-Heart®, effectively monitor heart transplant patients. In this trial, participants will be managed with HeartCare, which studies have found can identify transplant-related issues and reduce the need for invasive biopsies that require tissue samples for testing. Survival rates and heart function after a transplant remain similar to traditional methods but with fewer complications. Specifically, the average heart function, measured by the percentage of blood the heart pumps out with each beat, remained around 61% up to two years post-transplant. This suggests that HeartCare provides a reliable, noninvasive way to monitor heart transplant patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Jeffrey Teuteberg

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Surveillance

Participants are monitored using HeartCare testing services, including AlloMap and AlloSure-Heart, to assess for allograft rejection

2 years

Follow-up

Participants are monitored for clinical outcomes, including the development of de-novo DSA, up to 5 years post-transplant

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care

How Is the Trial Designed?

Group I: HeartCare Experimental Treatment 1 Intervention

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

Group II: Control Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

CareDx

Lead Sponsor

Trials

26

Recruited

15,500+

Citations

1. caredx.com caredx.com/products-and-services/transplant-services/heart/heartcare/

Identify Heart Transplant Injury With HeartCare Post-transplant survival, rejection free survival and graft function were similar at 1 year, while requiring significantly fewer endomyocardial biopsies.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03695601

NCT03695601 | Surveillance HeartCare® Outcomes Registry This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart ...

3. jhltonline.org jhltonline.org/article/S1053-2498(24)01659-0/fulltext

Surveillance with dual noninvasive testing for acute cellular ... The mean left ventricular ejection fraction was 61% ± 6% at both 1- and 2-years post-transplant. Graft dysfunction was present in 3.3% of ...

4. caredx.com caredx.com/products-and-services/transplant-services/heart/allomap/

AlloMap AlloMap allows for noninvasive surveillance of heart transplant recipients. It is used by over 90% of transplant centers, and since approval has been used over ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6064662/

Clinical Phenomapping and Outcomes after Heart ... Survival after heart transplantation (HTx) is limited by complications related to alloreactivity, immune suppression, and side effects of pharmacological ...

6. investors.caredx.com investors.caredx.com/news/news-details/2025/CareDx-Announces-Largest-Landmark-Study-of-Its-Kind-on-Antibody-Mediated-Rejection-in-Heart-Transplantation-Published-in-Journal-of-the-American-College-of-Cardiology-Heart-Failure/default.aspx

CareDx Announces Largest Landmark Study of Its Kind on ... AlloSure, in combination with AlloMap, form HeartCare – a non-invasive and clinically validated approach to heart transplant surveillance.

7. caredx.com caredx.com/wp-content/uploads/2024/07/SHORE-Publication-2024.pdf

Surveillance with dual noninvasive testing for acute cellular ... 5,6 The Surveillance. HeartCare Outcomes Registry (SHORE) is a large, multi- center prospective registry in the United States of heart transplant patients ...

8. clinicaltrial.be clinicaltrial.be/en/details/6532?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Surveillance HeartCare® Outcomes Registry - Clinical Tria... AlloSure-Heart monitors graft injury. AlloMap is the first FDA cleared test and is the only non-invasive, blood test method recommended in the ...