Outcomes AlloMap Registry: the Long-term Management and Outcomes of Heart Transplant Recipients With AlloMap Testing (OAR)
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
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Phoenix, Arizona, Estados Unidos, 85054
- Mayo Clinic
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California
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Beverly Hills, California, Estados Unidos, 90211
- Cedars-Sinai Medical Center
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Los Angeles, California, Estados Unidos, 90095
- University of California, Los Angeles
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Stanford, California, Estados Unidos, 94305
- Stanford University
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- University of Florida,
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Hollywood, Florida, Estados Unidos, 33021
- Memorial Regional Hospital
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Tampa, Florida, Estados Unidos, 33606
- Tampa General Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46260
- St. Vincent Medical Group
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- University of Louisville
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Clinic Foundation
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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Missouri
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Kansas City, Missouri, Estados Unidos, 64111
- Mid America Heart Institute - St. Luke's Hospital
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University Medical Center
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New York, New York, Estados Unidos, 10029
- Mount Sinai Hospital
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73112
- Integris Baptist Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- Temple University
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Philadelphia, Pennsylvania, Estados Unidos, 19102
- Drexel University
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Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, Estados Unidos, 15219
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern Medical Center
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Dallas, Texas, Estados Unidos, 75246
- Baylor Research Institute
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Research Institute
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Houston, Texas, Estados Unidos, 77030
- Baylor St. Lukes
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Utah
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Murray, Utah, Estados Unidos, 84107
- Intermountain Heart Institute
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Virginia
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Falls Church, Virginia, Estados Unidos, 22042
- Inova Heart & Vascular Institute
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53215
- Aurora St. Luke's Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Heart transplant recipients
Heart transplant rejection surveillance including AlloMap testing
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Vital status of heart transplant recipient
Periodo de tiempo: 5 Years
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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 |
5 Years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Surveillance visit schedules and patient management parameters
Periodo de tiempo: 5 Years
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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
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5 Years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: James P Yee, MD, PhD, CareDx, Inc., Brisbane, CA
Publicaciones y enlaces útiles
Publicaciones Generales
- Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Elashoff B, Baron H, Yee J, Valantine HA; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010 May 20;362(20):1890-900. doi: 10.1056/NEJMoa0912965. Epub 2010 Apr 22.
- Shah MR, Starling RC, Schwartz Longacre L, Mehra MR; Working Group Participants. Heart transplantation research in the next decade--a goal to achieving evidence-based outcomes: National Heart, Lung, And Blood Institute Working Group. J Am Coll Cardiol. 2012 Apr 3;59(14):1263-9. doi: 10.1016/j.jacc.2011.11.050.
- Kanwar, M. et al: Correlation of Longitudinal Gene-Expression Profiling Score to Cytomegalovirus (CMV) Infection: Results from the Outcomes AlloMap Registry (OAR). ISHLT 35th Annual Meeting and Scientific Sessions. 2015 April 13-18, 2015; Nice, France. *2015 American Transplant Congress. May 2-6, 2015; Philadelphia, PA. Poster.
- Teuteberg, J. et al; Gene-Expression Profiling to Monitor for Rejection-Which Patients are Being Offered This Strategy? ISHLT 35th Annual Meeting and Scientific Sessions. 2015 April 13-18, 2015; Nice, France. 2015. *American Transplant Congress. May 2-6, 2015; Philadelphia, PA. Poster.
- Sulemanjee, N. et al; Gender-Mismatched Heart Transplants and Gene Expression Profiling Score-Lessons Learned from the Outcomes AlloMap Registry (OAR). ISHLT 35th Annual Meeting and Scientific Sessions. 2015 April 13-18, 2015; Nice, France. 2015 *American Transplant Congress. May 2-6, 2015; Philadelphia, PA. Poster.
- Kanwar, M. et al; Impact of Cytomegalovirus Infection on Longitudinal Gene-Expression Profiling Score: Results from the Outcomes AlloMap Registry. 2016 ISHLT 36th Annual Meeting and Scientific Sessions. April 27-30, 2016; Washington, DC.
- Teuteberg, JJ. et al; Higher Rate of Hospitalizations for Infection and Cancer Then Rejection in Low Risk Heart Transplant Patients Followed by Gene Expression Profiling. 2016 ISHLT 36th Annual Meeting and Scientific Sessions. April 27-30, 2016; Washington, DC.
- Teuteberg, JJ. et al; Gene Expression Profiling Score and the Risk of Infection in Heart Transplant. 2016 American Transplant Congress. June 12, 2016; Boston, MA Poster
- Teuteberg, J., Shullo, MA., Rinde-Hoffman, D., Wigger, M., Wang, YS., Wolf, T., Arnold, PJ., Sninsky, J., Berman, P. Routine Surveillance of Heart Transplant Recipients with Gene Expression Profiling: Lack of an Impact of Race on Outcomes. 2017 American Transplant Congress. April 29-May 3, 2017; Chicago, IL. Poster
- Shah, P. et al: Outcomes with Gene Expression Profiling for Cardiac Transplant Recipients Within North America. 2016 ISHLT 36th Annual Meeting and Scientific Sessions. April 27-30, 2016; Washington, DC.
- Uriel, N. et al; Utility of Gene Expression (AlloMap Score) in Antibody Mediated Rejection Detection. 2016 ISHLT 36th Annual Meeting and Scientific Sessions. April 27-30, 2016; Washington, DC.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SN-C-00003
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