Overview

This trial is active, not recruiting.

Conditions graft rejection, heart diseases
Treatments endomyocardial biopsy, allomap molecular testing
Sponsor XDx
Start date August 2009
End date December 2011
Trial size 40 participants
Trial identifier NCT00962377, CA-0007

Summary

This study is designed to evaluate the safety and efficacy of a peripheral blood mononuclear cell gene expression profiling method (AlloMap) in monitoring asymptomatic heart transplant patients for acute rejection beginning 2-6 months(≥ 55-185 days) after transplantation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
Gene expression profiling in the monitoring of asymptomatic heart transplant patients for acute cellular rejection.
allomap molecular testing GEP
Gene expression profiling in the monitoring of asymptomatic heart transplant patients for acute cellular rejection.
(Active Comparator)
Right ventricular endomyocardial biopsy in the monitoring of asymptomatic heart transplant patients for acute cellular rejection
endomyocardial biopsy EMB
Right ventricular endomyocardial biopsy in monitoring of asymptomatic heart transplant patients for acute cellular rejection

Primary Outcomes

Measure
Event-Free Survival and intravascular ultrasound (IVUS) measures
time frame: 1.5 years

Secondary Outcomes

Measure
Time from enrollment to death from any cause, and cause of death.
time frame: 1.5 years
Number of biopsies performed.
time frame: 1.5 years
Time from study enrollment to biopsy-related complications, as well as the number and type of biopsy-related complications.
time frame: 1.5 years
QOL responses as collected from the SF-12 form
time frame: Enrollment and one year post-transplant
Biopsy-related patient preferences satisfaction using a non-validated survey
time frame: Enrollment and one year post transplant
Objective measurements of cardiac function
time frame: 1.5 years
Gene expression profiling scores and immunosuppressant doses
time frame: 1.5 years
Number of rejection episodes.
time frame: 1.5 years
Utilization of AlloMap or biopsy to manage corticosteroid weaning between month 6 and month 12 post-transplant.
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Heart transplant recipients who are 2-6 months (≥55 days -185 days) post-transplant at the time of the first study surveillance visit 2. Age ≥ 18 years 3. Left ventricular ejection fraction ≥ 50% by Echocardiography, Multiple Gated Acquisition (MUGA) scan, or ventriculography at study entry (baseline / enrollment study) Exclusion Criteria: 1. Any clinical signs of declining graft function: - Symptoms of Congestive Heart Failure (CHF) at the first study surveillance visit - Signs of decompensated heart failure, including the development of a new S3 gallop at the enrollment visit - Elevated right heart pressures with diminished cardiac index < 2.2 L/min/m2 that is new compared to a previous measurement within 2 months - Decrease in LVEF as measured by echocardiography: ≥ 25% compared to prior measurement within 2 months 2. Rejection therapy for biopsy-proven ISHLT Grade 3A or higher during the preceding 2 months 3. Prior or current evidence of antibody-mediated rejection (AMR). AMR is defined according to the ISHLT 2004 Guidelines as positive histology and immunopathology (either immunofluorescence or immunoperoxidase) staining for AMR 4. Major changes in immunosuppression therapy within previous 30 days (e.g., discontinuation of calcineurin inhibitors, switch from mycophenolate mofetil to sirolimus or vice versa) 5. Unable to give written informed consent 6. Patient receiving hematopoietic growth factors (e.g., Neupogen, Epogen) currently or during the previous 30 days 7. Patients receiving ≥ 20 mg/day of prednisone equivalent corticosteroids at the time of first study surveillance visit 8. Patient enrolled in a trial requiring routine surveillance endomyocardial biopsies 9. Patient received transfusion within preceding 4 weeks 10. Patients with end-stage renal disease requiring some form of renal replacement therapy (hemodialysis or peritoneal dialysis) 11. Pregnancy at the time of first study surveillance visit

Additional Information

Official title Early Invasive Monitoring Attenuation Through Gene Expression (EIMAGE) Trial
Description Cardiac allograft rejection is experienced by 20-50% of patients at least once during the first year after cardiac transplantation under the present immunosuppression regimens. The standard for rejection surveillance has been the endomyocardial biopsy (EMB). However, EMB is invasive, causes morbidity, and is subject to sampling error and inter-observer variability. Gene expression profiling (GEP), with its high negative predictive value (NPV) for acute cellular rejection (ACR), appears to be well suited to identify low-risk patients who can be safely managed without routine invasive endomyocardial biopsy (EMB). The Invasive Monitoring Attenuation through Gene Expression (IMAGE) multicenter study was conducted between the years 2005-2009 and studied patients who were >6 months-5 years post transplant. The IMAGE study demonstrated that the clinical outcome of heart transplant patients managed with AlloMap® was noninferior to patients managed with EMB. The EIMAGE study expands the time window under study to include patients who are 2 months (≥ 55 days) post-transplant. This earlier time frame of study is the primary difference between the EIMAGE study and the IMAGE study.
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by XDx.