Surveillance HeartCare® Outcomes Registry
- Conditions
- Heart Transplant Rejection
- Interventions
- Other: Standard of Care
- Registration Number
- NCT03695601
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2743
- Patients who are 15 years of age or older at the time of blood draw.
- Received a heart transplant (primary or repeat)
- Patients who have HeartCare initiated within 3 months post-transplant
- Patients who are pregnant at the time of blood draw.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Standard of Care 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. HeartCare Standard of Care Diagnostic Test: Heart Care 2300 patients managed with HeartCare (AlloMap® and AlloSure-Heart® )
- Primary Outcome Measures
Name Time Method Proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant. Dec-2026 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (67)
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Medical City Dallas
🇺🇸Dallas, Texas, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Baptist Health Arkansas
🇺🇸Little Rock, Arkansas, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of California San Fransisco Medical Center
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
Yale New Haven
🇺🇸New Haven, Connecticut, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Mayo Clinic- Florida
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Advent Health
🇺🇸Orlando, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Ascension St. Vincent Hospital and Health Care Center
🇺🇸Indianapolis, Indiana, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
St. Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Barnes Jewish Hospital, Washington University
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Northwell Health/ North Shore University Hospital
🇺🇸Manhasset, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny-Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
Saint Thomas Health
🇺🇸Nashville, Tennessee, United States
Ascension Seton
🇺🇸Austin, Texas, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Baylor St. Luke's Medical Center
🇺🇸Houston, Texas, United States
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
UTHealth/ Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Methodist Healthcare Systems of San Antonio
🇺🇸San Antonio, Texas, United States
Intermountain Heart Institute
🇺🇸Murray, Utah, United States
Inova Fairfax Medical Campus
🇺🇸Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Wisconsin School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Aurora Research Institute
🇺🇸Milwaukee, Wisconsin, United States