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

Use our guide to learn which trials are right for you!

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
We found this trial at
36
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Michael Shullo, PharmD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Robert Cole, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Jayant Raikhelkar, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Los Angeles, California 90095
310-825-4321
Principal Investigator: Eugene DePasquale, MD
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Mark Wigger, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Peter Berman, MD
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Monica Colvin, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Beverly Hills, California 90211
Principal Investigator: Jon Kobashigawa, MD
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Esther Vorovich, MD
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Randall Starling, MD
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Sitaramesh Emani, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Principal Investigator: Shelley Hall, MD
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Pradeep Mammen, MD
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Falls Church, Virginia 22042
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Hollywood, Florida 33021
Principal Investigator: Ioana Dumitru, MD
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Andrew Civitello, MD
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Arvind Bhimaraj, MD
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46290
Principal Investigator: Ashwin Ravichandran, MD
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kansas City, Missouri
Principal Investigator: Andrew Kao, MD
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
Principal Investigator: Navin Rajagopalan, MD
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Murray, Utah 84143
Principal Investigator: Abdallah G Kfoury, MD
?
mi
from
Murray, UT
Click here to add this to my saved trials
New Orleans, Louisiana 70121
Principal Investigator: Selim Krim, MD
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10029
Principal Investigator: Sean Pinney, MD
?
mi
from
New York, NY
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Farhana Latif, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Lynn Punnoose, MD
Temple University Temple University is many things to many people. A place to pursue life's...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Principal Investigator: Robert Scott, MD
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Manreet Kanwar, MD
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Keyur Shah, MD
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Principal Investigator: Gregory Ewald, MD
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Kiran Khush, MD
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
?
mi
from
Stanford, CA
Click here to add this to my saved trials