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

NCT00962377 | Unknown

• 1 other identifier: CA-0007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 acute rejection beginning 2-6 months(≥ 55-185 days) after transplantation.

Conditions

Graft Rejection; Heart Diseases

Keywords

molecular expression testing; right ventricular endomyocardial biopsy

Outcome Measures

Primary Outcomes (1)

• Event-Free Survival and intravascular ultrasound (IVUS) measures

  Event-Free Survival (EFS) is a composite of: the development of hemodynamic compromise with rejection, allograft dysfunction (hemodynamic compromise without histologically confirmed rejection), death from any cause, or re-transplantation. IVUS co-primary endpoint: maximal intimal thickness of the coronary arteries from baseline (measured at 6 weeks ± 30 days) to month 12 of ≥0.5mm, as measured by IVUS.

  1.5 years

Secondary Outcomes (9)

• Time from enrollment to death from any cause, and cause of death.

  1.5 years

• Number of biopsies performed.

  1.5 years

• Time from study enrollment to biopsy-related complications, as well as the number and type of biopsy-related complications.

  1.5 years

• QOL responses as collected from the SF-12 form

  Enrollment and one year post-transplant

• Biopsy-related patient preferences satisfaction using a non-validated survey

  Enrollment and one year post transplant

Study Arms (2)

AlloMap Molecular testing

OTHER

Gene expression profiling in the monitoring of asymptomatic heart transplant patients for acute cellular rejection.

Procedure: AlloMap Molecular Testing

Endomyocardial biopsy

ACTIVE COMPARATOR

Right ventricular endomyocardial biopsy in the monitoring of asymptomatic heart transplant patients for acute cellular rejection

Procedure: Endomyocardial biopsy

Interventions

Endomyocardial biopsy PROCEDURE

Right ventricular endomyocardial biopsy in monitoring of asymptomatic heart transplant patients for acute cellular rejection

Also known as: EMB

Endomyocardial biopsy

AlloMap Molecular Testing PROCEDURE

Gene expression profiling in the monitoring of asymptomatic heart transplant patients for acute cellular rejection.

Also known as: GEP

AlloMap Molecular testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• XDx: lead

Study Sites (1)

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

Location

Related Publications (5)

• Deng MC, Eisen HJ, Mehra MR, Billingham M, Marboe CC, Berry G, Kobashigawa J, Johnson FL, Starling RC, Murali S, Pauly DF, Baron H, Wohlgemuth JG, Woodward RN, Klingler TM, Walther D, Lal PG, Rosenberg S, Hunt S; CARGO Investigators. Noninvasive discrimination of rejection in cardiac allograft recipients using gene expression profiling. Am J Transplant. 2006 Jan;6(1):150-60. doi: 10.1111/j.1600-6143.2005.01175.x.

  PMID: 16433769 BACKGROUND

• Starling RC, Pham M, Valantine H, Miller L, Eisen H, Rodriguez ER, Taylor DO, Yamani MH, Kobashigawa J, McCurry K, Marboe C, Mehra MR, Zuckerman A, Deng MC; Working Group on Molecular Testing in Cardiac Transplantation. Molecular testing in the management of cardiac transplant recipients: initial clinical experience. J Heart Lung Transplant. 2006 Dec;25(12):1389-95. doi: 10.1016/j.healun.2006.10.002. No abstract available.

  PMID: 17178330 BACKGROUND

• Evans RW, Williams GE, Baron HM, Deng MC, Eisen HJ, Hunt SA, Khan MM, Kobashigawa JA, Marton EN, Mehra MR, Mital SR. The economic implications of noninvasive molecular testing for cardiac allograft rejection. Am J Transplant. 2005 Jun;5(6):1553-8. doi: 10.1111/j.1600-6143.2005.00869.x.

  PMID: 15888068 BACKGROUND

• Marboe CC, Billingham M, Eisen H, Deng MC, Baron H, Mehra M, Hunt S, Wohlgemuth J, Mahmood I, Prentice J, Berry G. Nodular endocardial infiltrates (Quilty lesions) cause significant variability in diagnosis of ISHLT Grade 2 and 3A rejection in cardiac allograft recipients. J Heart Lung Transplant. 2005 Jul;24(7 Suppl):S219-26. doi: 10.1016/j.healun.2005.04.001.

  PMID: 15993777 BACKGROUND

• Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Elashoff B, Baron H, Yee J, Valantine HA; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010 May 20;362(20):1890-900. doi: 10.1056/NEJMoa0912965. Epub 2010 Apr 22.

  PMID: 20413602 RESULT

Related Links

• Information on molecular expression testing
• Sponsor's website

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Upen Patil, MD

  XDx, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 21, 2010

Record last verified: 2010-12

Locations

US (1)