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

Heart Diseases Clinical Trial

— OAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01833195
• Other study ID #: SN-C-00003
• Status: Active, not recruiting
• Start date: March 2013
• Est. completion date: February 2020

Study information

• Verified date: December 2019
• Source: CareDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2444
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Transplant Failure
• Cardiac Transplant Rejection
• Heart Diseases

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Cedars-Sinai Medical Center	Beverly Hills	California
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Baylor Research Institute	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Inova Heart & Vascular Institute	Falls Church	Virginia
United States	University of Florida,	Gainesville	Florida
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Baylor St. Lukes	Houston	Texas
United States	Houston Methodist Research Institute	Houston	Texas
United States	St. Vincent Medical Group	Indianapolis	Indiana
United States	Mid America Heart Institute - St. Luke's Hospital	Kansas City	Missouri
United States	University of Kentucky	Lexington	Kentucky
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Intermountain Heart Institute	Murray	Utah
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Drexel University	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Washington University	Saint Louis	Missouri
United States	Stanford University	Stanford	California
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CareDx

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. *2

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.

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. — View Citation

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. Review. — View Citation

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.

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

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,

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 T

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, 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; Washingto

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.

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital status of heart transplant recipient	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
Secondary	Surveillance visit schedules and patient management parameters	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

External Links

•   Click here for more information about AlloMap testing