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

3. februar 2020 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

2444

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

15 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

CareDx

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2013

Primær fullføring (Forventet)

1. februar 2020

Studiet fullført (Forventet)

1. februar 2020

Datoer for studieregistrering

Først innsendt

11. april 2013

Først innsendt som oppfylte QC-kriteriene

15. april 2013

Først lagt ut (Anslag)

16. april 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. februar 2020

Sist bekreftet

1. desember 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

SN-C-00003

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .