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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.
 
ClinicalTrials.gov Identifier: NCT03695601
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
CareDx

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.

Condition or disease Intervention/treatment
Heart Transplant Rejection Other: Standard of Care

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.

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance HeartCare® Outcomes Registry
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2027

Group/Cohort Intervention/treatment
HeartCare
Diagnostic Test: Heart Care 1600 patients managed with HeartCare (AlloMap® and AlloSure-Heart® )
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 800 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
Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody




Primary Outcome Measures :
  1. Percentage of patients alive at one, two and three years post-transplantation. [ Time Frame: Dec-2024 ]

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


Information from the National Library of Medicine

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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
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.

Criteria

Inclusion Criteria:

  1. Patients who are 15 years of age or older at the time of blood draw.
  2. Heart transplant recipients who are selected by their health care provider to be managed with HeartCare.
  3. Patients who are selected by their health care provider to be managed following the Heart Routine Testing Schedule (HARTS) or a derivative of the schedule that has been defined by the provider.
  4. Patients who provide written informed consent.
  5. Patients who have HeartCare initiated within 30 days of signing the informed consent form.

Exclusion Criteria:

  1. Patients who are less than 15 years of age at the time of blood draw.
  2. Heart transplant recipients who are not managed with HeartCare.
  3. Patients who are not managed following the Heart Routine Testing Schedule (HARTS) or a derivative of the schedule that has been defined by the provider.
  4. Patients who are pregnant at the time of blood draw.
  5. Patients who do not provide written informed consent.

Information from the National Library of Medicine

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


Contacts
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Contact: Sham Dholakia 415-287-2374 sdholakia@caredx.com

Locations
Show Show 31 study locations
Sponsors and Collaborators
CareDx
Investigators
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Study Director: James P Yee, MD, PhD CareDx
Publications:

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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: June 23, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No