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Surveillance HeartCare® Outcomes Registry (SHORE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03695601
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : March 2, 2021
Information provided by (Responsible Party):

Tracking Information
First Submitted Date September 28, 2018
First Posted Date October 4, 2018
Last Update Posted Date March 2, 2021
Actual Study Start Date December 28, 2018
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2018)
Percentage of patients alive at one, two and three years post-transplantation. [ Time Frame: Dec-2024 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Surveillance HeartCare® Outcomes Registry
Official Title Surveillance HeartCare® Outcomes Registry
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
For AlloMap, RNA isolated from peripheral blood mononuclear cells (PBMC) For AlloSure-Heart, plasma from venous blood will be collected and cell-free DNA will be extracted from the plasma for analysis of donor-derived cell-free DNA
Sampling Method Probability Sample
Study Population

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.

Condition Heart Transplant Rejection
Intervention Other: Standard of Care
Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody
Study Groups/Cohorts
  • HeartCare
    Diagnostic Test: Heart Care 2300 patients managed with HeartCare (AlloMap® and AlloSure-Heart® )
    Intervention: Other: Standard of Care
  • 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.
    Intervention: Other: Standard of Care
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 26, 2021)
Original Estimated Enrollment
 (submitted: October 2, 2018)
Estimated Study Completion Date June 2027
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Sham Dholakia 415-287-2374
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT03695601
Other Study ID Numbers SN-C-00011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party CareDx
Study Sponsor CareDx
Collaborators Not Provided
Study Director: James P Yee, MD, PhD CareDx
PRS Account CareDx
Verification Date February 2021