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Active, Not Recruiting

NCT Number: 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 transplant recipients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Transplant Rejection

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Arizona, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients who are pregnant at the time of blood draw.

Treatment and study plan

Standard of care

Other

Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody

Primary outcomes

  1. Proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

CareDx

Industry

Registry information

Acronym: SHORE

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2018
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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