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

3. februar 2020 opdateret af: CareDx

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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2444

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Arizona
  - Phoenix, Arizona, Forenede Stater, 85054
    - Mayo Clinic
- California
  - Beverly Hills, California, Forenede Stater, 90211
    - Cedars-Sinai Medical Center
  - Los Angeles, California, Forenede Stater, 90095
    - University of California, Los Angeles
  - Stanford, California, Forenede Stater, 94305
    - Stanford University
- Florida
  - Gainesville, Florida, Forenede Stater, 32610
    - University of Florida,
  - Hollywood, Florida, Forenede Stater, 33021
    - Memorial Regional Hospital
  - Tampa, Florida, Forenede Stater, 33606
    - Tampa General Hospital
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30322
    - Emory University
- Illinois
  - Chicago, Illinois, Forenede Stater, 60611
    - Northwestern University
  - Chicago, Illinois, Forenede Stater, 60637
    - University of Chicago
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46260
    - St. Vincent Medical Group
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40536
    - University of Kentucky
  - Louisville, Kentucky, Forenede Stater, 40202
    - University of Louisville
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70121
    - Ochsner Clinic Foundation
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48109
    - University of Michigan
- Minnesota
  - Minneapolis, Minnesota, Forenede Stater, 55455
    - University of Minnesota
- Missouri
  - Kansas City, Missouri, Forenede Stater, 64111
    - Mid America Heart Institute - St. Luke's Hospital
  - Saint Louis, Missouri, Forenede Stater, 63110
    - Washington University
- New York
  - New York, New York, Forenede Stater, 10032
    - Columbia University Medical Center
  - New York, New York, Forenede Stater, 10029
    - Mount Sinai Hospital
- Ohio
  - Cleveland, Ohio, Forenede Stater, 44195
    - Cleveland Clinic Foundation
  - Columbus, Ohio, Forenede Stater, 43210
    - Ohio State University
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73112
    - Integris Baptist Medical Center
- Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19140
    - Temple University
  - Philadelphia, Pennsylvania, Forenede Stater, 19102
    - Drexel University
  - Pittsburgh, Pennsylvania, Forenede Stater, 15212
    - Allegheny General Hospital
  - Pittsburgh, Pennsylvania, Forenede Stater, 15219
    - University of Pittsburgh Medical Center
- Tennessee
  - Nashville, Tennessee, Forenede Stater, 37232
    - Vanderbilt University Medical Center
- Texas
  - Dallas, Texas, Forenede Stater, 75390
    - UT Southwestern Medical Center
  - Dallas, Texas, Forenede Stater, 75246
    - Baylor Research Institute
  - Houston, Texas, Forenede Stater, 77030
    - Houston Methodist Research Institute
  - Houston, Texas, Forenede Stater, 77030
    - Baylor St. Lukes
- Utah
  - Murray, Utah, Forenede Stater, 84107
    - Intermountain Heart Institute
- Virginia
  - Falls Church, Virginia, Forenede Stater, 22042
    - Inova Heart & Vascular Institute
  - Richmond, Virginia, Forenede Stater, 23298
    - Virginia Commonwealth University
- Wisconsin
  - Milwaukee, Wisconsin, Forenede Stater, 53215
    - Aurora St. Luke's Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

15 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Heart transplant patients

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
Heart transplant recipients Heart transplant rejection surveillance including AlloMap testing

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Vital status of heart transplant recipient Tidsramme: 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	5 Years

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Surveillance visit schedules and patient management parameters Tidsramme: 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	5 Years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

CareDx

Efterforskere

Studieleder: James P Yee, MD, PhD, CareDx, Inc., Brisbane, CA

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2013

Primær færdiggørelse (Forventet)

1. februar 2020

Studieafslutning (Forventet)

1. februar 2020

Datoer for studieregistrering

Først indsendt

11. april 2013

Først indsendt, der opfyldte QC-kriterier

15. april 2013

Først opslået (Skøn)

16. april 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. februar 2020

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

SN-C-00003

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .