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.
Brief Title
Surveillance HeartCare® Outcomes Registry
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.
Completion Date
Completion Date Type
Estimated
Conditions
Heart Transplant Rejection
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.
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.
Inclusion 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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
15 Years
NCT Id
NCT03695601
Org Class
Industry
Org Full Name
CareDx
Org Study Id
SN-C-00011
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Surveillance HeartCare® Outcomes Registry
Primary Outcomes
Outcome Description
The primary endpoint of the study is the proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant. The overall incidence of de-novo DSA is between 10-20% in the first year and 10-15% each year subsequently.
Outcome Measure
Proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant.
Outcome Time Frame
Dec-2026
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
The control cohort will include the historical patients cared for without the use of HeartCare at the participating centers.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
15
Investigators
Investigator Type
Principal Investigator
Investigator Name
Omar Saeed
Investigator Email
osaeed@montefiore.org
Investigator Department
Medicine
Investigator Division
Cardiology
Investigator Sponsor Organization
External
Study Department
Medicine
Study Division
Cardiology
MeSH Terms
STANDARD OF CARE
QUALITY INDICATORS, HEALTH CARE
QUALITY OF HEALTH CARE
HEALTH SERVICES ADMINISTRATION
HEALTH CARE QUALITY, ACCESS, AND EVALUATION