Outcomes AlloMap Registry: the Long-term Management and Outcomes of Heart Transplant Recipients With AlloMap Testing
- Conditions
- Cardiac Transplant FailureHeart DiseasesCardiac Transplant Rejection
- Registration Number
- NCT01833195
- Lead Sponsor
- CareDx
- Brief Summary
The objective of this registry is to observe short and long term clinical outcomes in heart transplant recipients who receive regular AlloMap testing as part of allograft rejection surveillance.
- Detailed Description
The standard of care in adult heart transplant recipients has been to perform periodic endomyocardial biopsies for surveillance for rejection. Because of the risks and discomforts associated with the biopsy procedure, a non-invasive test (AlloMap) based on gene-expression profiling of peripheral blood was developed and introduced in 2005 to identify heart transplant recipients who have a low probability of rejection at the time of protocol surveillance testing. The schedule of AlloMap surveillance testing has been derived from the customary timing of surveillance biopsies: e.g. at 1 to 2 month intervals for patients who are 6 and 12 post-transplantation, and at 3, 4 or 6 months after the first year post-transplantation.
In the large multicenter IMAGE (Invasive Monitoring Attenuation by Gene Expression Profiling) 602 patients in the United States who had undergone cardiac transplantation at least 6 months prior were randomized 1:1 to either surveillance with routine biopsy or AlloMap testing. Patients in both groups were also monitored with echocardiography. A primary outcome event was defined as an episode of rejection with hemodynamic compromise, graft dysfunction due to other causes, death or retransplantation. Over a median follow-up period of 19 months, 297 patients who were monitored with AlloMap and 305 patients who underwent routine biopsies had similar 2-year cumulative rates of events (14.5% and 15.3%, respectively; hazard ratio with gene-expression profiling, 1.04; 95% confidence interval, 0.67 to 1.68).
This Outcomes AlloMap Registry (OAR) study is designed to collect similar clinical outcomes information as studied in IMAGE, in a larger cohort of patients (approximately 2000) followed for up to 5 years. At each routine clinic visit, key clinical features such as rejection surveillance management schedules, testing results (e.g. blood levels of immunosuppressive agents), and AlloMap scores will be collected. This larger and longer term follow-up dataset is intended to enable further elucidation, through analyses techniques such as multivariate Cox proportional hazards models, of the surveillance management features which may be associated or contribute to the most favorable long term outcomes of the heart recipients.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2444
- New and existing heart transplant recipients ≥ 2 months (≥ 55 days) post-transplant receiving post-transplant care at the enrolling centers for interim surveillance monitoring that includes AlloMap testing
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vital status of heart transplant recipient 5 Years Hospitalizations and causes (i.e. infections or graft dysfunction (classified as: acute cellular rejection, antibody mediated rejection , cardiac allograft vasculopathy or non specific etiology of graft dysfunction
Cancers (newly diagnosed and/or recurrent): onset and classification of types of cancers
- Secondary Outcome Measures
Name Time Method Surveillance visit schedules and patient management parameters 5 Years Endomyocardial biopsy and histology grades of rejection; left ventricular echocardiograms and ejection fractions; maintenance immunosuppressive drugs categories and doses/ blood levels; AlloMap scores and score patterns
Trial Locations
- Locations (36)
Cedars-Sinai Medical Center
🇺🇸Beverly Hills, California, United States
University of Florida,
🇺🇸Gainesville, Florida, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Stanford University
🇺🇸Stanford, California, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Mid America Heart Institute - St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Inova Heart & Vascular Institute
🇺🇸Falls Church, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Intermountain Heart Institute
🇺🇸Murray, Utah, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
St. Vincent Medical Group
🇺🇸Indianapolis, Indiana, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Mayo Clinic
🇺🇸Phoenix, Arizona, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor St. Lukes
🇺🇸Houston, Texas, United States
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States