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

Sponsor

CareDx (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01833195

Collaborator

(none)

2,444

Enrollment

Locations

83.1

Anticipated Duration (Months)

67.9

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Transplant Failure Cardiac Transplant Rejection Heart Diseases

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2444 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Heart transplant recipients Heart transplant rejection surveillance including AlloMap testing

Outcome Measures

Primary Outcome Measures

Vital status of heart transplant recipient [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

Secondary Outcome Measures

Surveillance visit schedules and patient management parameters [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Phoenix	Arizona	United States	85054
2	Cedars-Sinai Medical Center	Beverly Hills	California	United States	90211
3	University of California, Los Angeles	Los Angeles	California	United States	90095
4	Stanford University	Stanford	California	United States	94305
5	University of Florida,	Gainesville	Florida	United States	32610
6	Memorial Regional Hospital	Hollywood	Florida	United States	33021
7	Tampa General Hospital	Tampa	Florida	United States	33606
8	Emory University	Atlanta	Georgia	United States	30322
9	Northwestern University	Chicago	Illinois	United States	60611
10	University of Chicago	Chicago	Illinois	United States	60637
11	St. Vincent Medical Group	Indianapolis	Indiana	United States	46260
12	University of Kentucky	Lexington	Kentucky	United States	40536
13	University of Louisville	Louisville	Kentucky	United States	40202
14	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
15	University of Michigan	Ann Arbor	Michigan	United States	48109
16	University of Minnesota	Minneapolis	Minnesota	United States	55455
17	Mid America Heart Institute - St. Luke's Hospital	Kansas City	Missouri	United States	64111
18	Washington University	Saint Louis	Missouri	United States	63110
19	Mount Sinai Hospital	New York	New York	United States	10029
20	Columbia University Medical Center	New York	New York	United States	10032
21	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
22	Ohio State University	Columbus	Ohio	United States	43210
23	Integris Baptist Medical Center	Oklahoma City	Oklahoma	United States	73112
24	Drexel University	Philadelphia	Pennsylvania	United States	19102
25	Temple University	Philadelphia	Pennsylvania	United States	19140
26	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
27	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15219
28	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
29	Baylor Research Institute	Dallas	Texas	United States	75246
30	UT Southwestern Medical Center	Dallas	Texas	United States	75390
31	Baylor St. Lukes	Houston	Texas	United States	77030
32	Houston Methodist Research Institute	Houston	Texas	United States	77030
33	Intermountain Heart Institute	Murray	Utah	United States	84107
34	Inova Heart & Vascular Institute	Falls Church	Virginia	United States	22042
35	Virginia Commonwealth University	Richmond	Virginia	United States	23298
36	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215