Surveillance HeartCare® Outcomes Registry

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

December 2018

Estimated Primary Completion Date

December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Surveillance HeartCare® Outcomes Registry

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Other: Standard of Care
Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody

Study Arms

: HeartCare
Diagnostic Test: Heart Care 1600 patients managed with HeartCare (AlloMap® and AlloSure-Heart® )
: 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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1600

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 2027

Estimated Primary Completion Date

December 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

15 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

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

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

CareDx

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: James P Yee, MD, PhD CareDx

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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