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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03695601
Recruitment Status : Active, not recruiting
First Posted : October 4, 2018
Last Update Posted : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
CareDx

Study Description
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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.
Study Design
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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 : December 2024
Estimated Study Completion Date : June 2027
Groups and Cohorts
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Group/Cohort Intervention/treatment
HeartCare
Diagnostic Test: Heart Care 2300 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 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.
 Other: Standard of Care
Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody


Outcome Measures
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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

Eligibility Criteria
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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. 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.

Contacts and Locations
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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


Locations
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Sponsors and Collaborators
CareDx
Investigators
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Study Director: Sham Dholakia CareDx
More Information
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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: May 13, 2022
Last Verified: June 2021

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