Surveillance HeartCare® Outcomes Registry (SHORE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03695601 |
Recruitment Status :
Active, not recruiting
First Posted : October 4, 2018
Last Update Posted : February 8, 2023
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Condition or disease | Intervention/treatment |
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Heart Transplant Rejection | Other: Standard of Care |
Study Type : | Observational |
Estimated Enrollment : | 3450 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Surveillance HeartCare® Outcomes Registry |
Actual Study Start Date : | December 28, 2018 |
Estimated Primary Completion Date : | November 2026 |
Estimated Study Completion Date : | November 2026 |
Group/Cohort | Intervention/treatment |
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HeartCare
Diagnostic Test: Heart Care 2300 patients managed with HeartCare (AlloMap® and AlloSure-Heart® )
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Other: Standard of Care
Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody |
Control
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.
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Other: Standard of Care
Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody |
- Percentage of patients alive at one, two and three years post-transplantation. [ Time Frame: Dec-2024 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
All eligible heart transplant recipients who meet the inclusion/exclusion criteria will be a part of this observational study.
The control cohort will include the historical patients cared for without the use of HeartCare at the participating centers.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695601

Principal Investigator: | Jeffrey Teuteberg | Stanford University |
Responsible Party: | CareDx |
ClinicalTrials.gov Identifier: | NCT03695601 |
Other Study ID Numbers: |
SN-C-00011 |
First Posted: | October 4, 2018 Key Record Dates |
Last Update Posted: | February 8, 2023 |
Last Verified: | February 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |