Status:
UNKNOWN
A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection Early Post-transplantation
Lead Sponsor:
XDx
Conditions:
Graft Rejection
Heart Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ac...
Detailed 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 reject...
Eligibility Criteria
Inclusion
- Heart transplant recipients who are 2-6 months (≥55 days -185 days) post-transplant at the time of the first study surveillance visit
- Age ≥ 18 years
- Left ventricular ejection fraction ≥ 50% by Echocardiography, Multiple Gated Acquisition (MUGA) scan, or ventriculography at study entry (baseline / enrollment study)
Exclusion
- 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
- Rejection therapy for biopsy-proven ISHLT Grade 3A or higher during the preceding 2 months
- 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
- Major changes in immunosuppression therapy within previous 30 days (e.g., discontinuation of calcineurin inhibitors, switch from mycophenolate mofetil to sirolimus or vice versa)
- Unable to give written informed consent
- Patient receiving hematopoietic growth factors (e.g., Neupogen, Epogen) currently or during the previous 30 days
- Patients receiving ≥ 20 mg/day of prednisone equivalent corticosteroids at the time of first study surveillance visit
- Patient enrolled in a trial requiring routine surveillance endomyocardial biopsies
- Patient received transfusion within preceding 4 weeks
- Patients with end-stage renal disease requiring some form of renal replacement therapy (hemodialysis or peritoneal dialysis)
- Pregnancy at the time of first study surveillance visit
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00962377
Start Date
August 1 2009
End Date
December 1 2011
Last Update
December 21 2010
Active Locations (1)
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1
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211