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Open Access Study protocol

Remote noninvasive allograft rejection monitoring for heart transplant recipients: study protocol for the novel evaluation with home electrocardiogram and remote transmission (NEW HEART) study

Lynn V Doering1*, Kathleen Hickey2, David Pickham3, Belinda Chen4 and Barbara J Drew5

Author Affiliations

1 University of California, Los Angeles (UCLA), School of Nursing, 700 Tiverton Ave., Factor Building 4-266, Los Angeles, Ca 90095, USA

2 Columbia University, School of Nursing, 630 West 168th Street, New York, NY 10032, USA

3 University of California, San Francisco (UCSF), 2 Koret Way, N611H, San Francisco, CA 94143-0610, USA

4 University of California, Los Angeles (UCLA), School of Nursing 700 Tiverton Ave. Factor Building 4-266, Los Angeles, Ca 90095, USA

5 University of California, San Francisco (UCSF), 2 Koret Way, N611H, San Francisco, CA 94143-0610, USA

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BMC Cardiovascular Disorders 2012, 12:14  doi:10.1186/1471-2261-12-14

Published: 2 March 2012

Abstract

Background

Acute allograft rejection is a major cause of early mortality in the first year after heart transplantation in adults. Although endomyocardial biopsy (EMB) is not a perfect "gold standard" for a correct diagnosis of acute allograft rejection, it is considered the best available test and thus, is the current standard practice. Unfortunately, EMB is an invasive and costly procedure that is not without risk. Recent evidence suggests that acute allograft rejection causes delays in ventricular repolarization and thereby increases the cellular action potential duration resulting in a longer QT interval on the electrocardiogram (ECG). No prospective study to date has investigated whether such increases in the QT interval could provide early detection of acute allograft rejection. Therefore, in the Novel Evaluation With Home Electrocardiogram And Remote Transmission (NEW HEART) study, we plan to investigate the potential benefit of daily home QT interval monitoring to predict acute allograft rejection.

Methods/design

The NEW HEART study is a prospective, double-blind, multi-center descriptive research study. A sample of 325 adult heart transplant recipients will be recruited within six weeks of transplant from three sites in the United States. Subjects will receive the HeartViewâ„¢ ECG recorder and its companion Internet Transmitter, which will transmit the subject's ECG to a Core Laboratory. Subjects will be instructed to record and transmit an ECG recording daily for 6 months. An increase in the QTC interval from the previous day of at least 25 ms that persists for 3 consecutive days will be considered abnormal. The number and grade of acute allograft rejection episodes, as well as all-cause mortality, will be collected for one year following transplant surgery.

Discussion

This study will provide "real world" prospective data to determine the sensitivity and specificity of QTC as an early non invasive marker of cellular rejection in transplant recipients during the first post-transplant year. A non-invasive indicator of early allograft rejection in heart transplant recipients has the potential to limit the number and severity of rejection episodes by reducing the time and cost of rejection surveillance and by shortening the time to recognition of rejection.

Trial Registration

ClinicalTrials.gov: NCT01365806

Keywords:
ECG monitoring; QT interval; Heart transplantation; Allograft rejection