Home Electrocardiogram (ECG) Monitoring After Heart Transplantation (NEW HEART)
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ClinicalTrials.gov Identifier: NCT01365806
Recruitment Status :
First Posted : June 3, 2011
Last Update Posted : March 8, 2017
University of California, Los Angeles
University of California, San Francisco
Cedars-Sinai Medical Center
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Belinda Chen, University of California, Los Angeles
The long-term goal of this research is to apply novel technology for detection of donor organ (allograft) rejection to improve patient outcomes following heart transplantation. The specific goal of this study is to determine whether daily monitoring of the transplant recipient's electrocardiogram (ECG) using a simple home device with transmission to an ECG Core Laboratory would provide an early biomarker for acute rejection. Despite routine immunosuppressant drug therapy, acute rejection is common, especially within the first 6 months following transplant surgery. To detect rejection, frequent endomyocardial biopsies of heart tissue are performed. An endomyocardial biopsy is a costly and invasive procedure performed in a hospital cardiac catheterization laboratory that has associated risks. Recent evidence suggests that acute allograft rejection causes delays in ventricular repolarization resulting in a longer QT interval on the ECG. The specific aims of the study are to: 1) determine whether an increase in the QT interval during the first 6 months following heart transplant is a sensitive and specific biomarker for acute rejection; and 2) determine the timing of QT interval increases relative to biopsy-diagnosed stages of mild/moderate/severe rejection. The potential benefit of finding a simple ECG biomarker of allograph rejection that could be measured at home is that it might yield earlier detection of rejection, allow more timely therapy and reduce mortality from acute allograft rejection.
Condition or disease
Cardiac Transplant RejectionQt Interval, Variation in
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
adult heart transplant recipients from recruitment sites (Columbia University-New York Presbyterian Medical Center; University of California, Los Angeles; and Cedars-Sinai Medical Center
≥18 years of age
first heart transplant surgery
not enrolled in other research studies that conflict with study design
clinically unstable at time of enrollment (i.e. clinical symptoms of allograph impairment)