Surveillance HeartCare® Outcomes Registry



Status:Recruiting
Healthy:No
Age Range:15 - Any
Updated:3/24/2019
Start Date:December 28, 2018
End Date:June 2027
Contact:Quynh Tran
Email:qtran@caredx.com
Phone:415-287-2309

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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.

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.

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.
We found this trial at
6
sites
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Pradeep Mammen, MD
Phone: 214-645-8040
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Jon Kobashigawa, MD
Phone: 310-248-7134
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Principal Investigator: Shelley Hall, MD
Phone: 214-818-7639
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Dallas, TX
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Falls Church, Virginia 22042
Principal Investigator: Palak Shah, MD
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Falls Church, VA
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Kansas City, Missouri 64111
Principal Investigator: Andrew Kao, MD
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Kansas City, MO
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Kiran Khush, MD
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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