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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:15 - Any
Updated:3/15/2019
Start Date:March 2013
End Date:February 2020
Contact:Preethi Prasad
Email:pprasad@caredx.com
Phone:415-287-2558

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Outcomes AlloMap Registry Study: the Clinical Long-term Management and Outcomes of Heart Transplant Recipients With Regular Rejection Surveillance Including Use of AlloMap Gene-expression Profiling Testing

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.

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.

Inclusion Criteria:

- 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
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
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201 Dowman Dr
Atlanta, Georgia 30303
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5801 South Ellis Avenue
Chicago, Illinois 60637
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Gainesville, Florida 32610
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Los Angeles, California 90095
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Minneapolis, Minnesota 55455
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1211 Medical Center Dr
Nashville, Tennessee 37232
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1 Tampa General Cir
Tampa, Florida 33606
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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Beverly Hills, California 90211
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303 East Superior Street
Chicago, Illinois 60611
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2049 E 100th St
Cleveland, Ohio 44106
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281 W. Lane Ave
Columbus, Ohio 43210
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3310 Live Oak St
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2201 Inwood Rd
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Falls Church, Virginia 22042
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Hollywood, Florida 33021
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Houston, Texas 77030
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Indianapolis, Indiana 46290
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Lexington, Kentucky
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500 S Preston St
Louisville, Kentucky
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
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New Orleans, Louisiana 70121
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630 W 168th St
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1801 N Broad St
Philadelphia, Pennsylvania 19122
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
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320 E North Ave
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Richmond, Virginia 23298
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