A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection Early Post-transplantation

Status unconfirmed · Not applicable

Conditions studied: Graft Rejection, Heart Diseases

In brief

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.

Key facts

Study ID: NCT00962377
Run by: XDx
People needed: 40
Starts: 2009-08-01
Expected to finish: 2011-12-01
Last updated by the study team: 2010-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Cedars-Sinai Medical Center — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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