Last updated on September 2018

Outcomes AlloMap Registry: the Long-term Management and Outcomes of Heart Transplant Recipients With AlloMap Testing


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT01833195

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Manreet Kanwar, MD

Allegheny General Hospital
Pittsburgh, PA United States
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Preethi Prasad

Aurora St. Luke's Medical Center
Milwaukee, WI United States
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Robert Scott, MD

Mayo Clinic
Phoenix, AZ United States
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Jon Kobashigawa, MD

Cedars-Sinai Medical Center
Beverly Hills, CA United States
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Kiran Khush, MD

Stanford University
Stanford, CA United States
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Preethi Prasad

University of Florida,
Gainesville, FL United States
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Ioana Dumitru, MD

Memorial Regional Hospital
Hollywood, FL United States
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Peter Berman, MD

Tampa General Hospital
Tampa, FL United States
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Robert Cole, MD

Emory University
Atlanta, GA United States
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Esther Vorovich, MD

Northwestern University
Chicago, IL United States
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Jayant Raikhelkar, MD

University of Chicago
Chicago, IL United States
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Ashwin Ravichandran, MD

St. Vincent Medical Group
Indianapolis, IN United States
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Navin Rajagopalan, MD

University of Kentucky
Lexington, KY United States
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Preethi Prasad

University of Louisville
Louisville, KY United States
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Selim Krim, MD

Ochsner Clinic Foundation
New Orleans, LA United States
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Monica Colvin, MD

University of Michigan
Ann Arbor, MI United States
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Preethi Prasad

University of Minnesota
Minneapolis, MN United States
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Andrew Kao, MD

Mid America Heart Institute - St. Luke's Hospital
Kansas City, MO United States
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Gregory Ewald, MD

Washington University
Saint Louis, MO United States
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Sean Pinney, MD

Mount Sinai Hospital
New York, NY United States
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Farhana Latif, MD

Columbia University Medical Center
New York, NY United States
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Randall Starling, MD

Cleveland Clinic Foundation
Cleveland, OH United States
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Sitaramesh Emani, MD

Ohio State University
Columbus, OH United States
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Preethi Prasad

Integris Baptist Medical Center
Oklahoma City, OK United States
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Preethi Prasad

Drexel University
Philadelphia, PA United States
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Lynn Punnoose, MD

Temple University
Philadelphia, PA United States
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Michael Shullo, PharmD

University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Mark Wigger, MD

Vanderbilt University Medical Center
Nashville, TN United States
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Shelley Hall, MD

Baylor Research Institute
Dallas, TX United States
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Pradeep Mammen, MD

UT Southwestern Medical Center
Dallas, TX United States
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Andrew Civitello, MD

Baylor St. Lukes
Houston, TX United States
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Arvind Bhimaraj, MD

Houston Methodist Research Institute
Houston, TX United States
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Abdallah G Kfoury, MD

Intermountain Heart Institute
Murray, UT United States
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Preethi Prasad

Inova Heart & Vascular Institute
Falls Church, VA United States
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Keyur Shah, MD

Virginia Commonwealth University
Richmond, VA United States
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Eugene DePasquale, MD

University of California, Los Angeles
Los Angeles, CA United States
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