Status:
COMPLETED
IMAGE: A Comparison of AlloMap Molecular Testing and Traditional Biopsy-based Surveillance for Heart Transplant Rejection
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 leukocyte gene expression profiling method in the monitoring of asymptomatic heart transplant patients for acute rejection.
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. With a higher incidence...
Eligibility Criteria
Inclusion
- Heart transplant recipients who are \> 6 months to 5 years (\> 6-60 months) post-transplant.
- Age ≥ 18 years.
- Stable outpatient being seen for routine monitoring of rejection. Stability is defined as absence of prior or current evidence of either severe cardiac allograft vasculopathy (CAV) or antibody-mediated rejection (AMR) with associated hemodynamic compromise.
- Severe CAV is defined as either
- \> 50% left main stenosis;
- ≥ 50% stenosis in ≥ 2 primary vessels (proximal 1/3 or middle 1/3 of the LAD or LCx, RCA to takeoff of PDA in right-dominant coronary circulations) or
- Isolated branch stenoses of \> 50% in all 3 systems (diagonal branches, obtuse marginal branches, distal 1/3 of LAD or LCx, PDA, PLB, and RCA to takeoff of PDA in non-dominant systems).
- AMR with associated hemodynamic compromise is defined as AMR (defined according to local criteria) with either
- A left ventricular ejection fraction (LVEF) ≤ 30% or at least 25% lower than the baseline value,
- A cardiac index \< 2 l/min/m2, or
- The use of inotropic agents to support circulation.
- Left ventricular ejection fraction ≥ 45% by Echocardiography, Multiple Gated Acquisition (MUGA) scan, or ventriculography at study entry (baseline / enrollment study).
Exclusion
- Patients \< 7 calendar months after heart transplantation.
- Any clinical signs of declining graft function:
- Symptoms of Congestive Heart Failure (CHF) at the enrollment 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 6 months.
- Decrease in LVEF as measured by echocardiography: ≥ 25% compared to prior measurement within 6 months.
- Rejection therapy for biopsy-proven ISHLT Grade 3A or higher during the preceding 2 months.
- 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 enrollment.
- 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 enrollment.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
629 Patients enrolled
Trial Details
Trial ID
NCT00351559
Start Date
January 1 2005
End Date
October 1 2009
Last Update
November 20 2009
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
2
Stanford University Medical Center
Stanford, California, United States, 94305
3
Northwestern University
Chicago, Illinois, United States, 60611
4
University of Chicago
Chicago, Illinois, United States, 60637