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Home Electrocardiogram (ECG) Monitoring After Heart Transplantation (NEW HEART)

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ClinicalTrials.gov Identifier: NCT01365806
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : March 8, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 Rejection Qt Interval, Variation in

Study Design

Study Type : Observational
Actual Enrollment : 345 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home ECG Monitoring to Detect Allograft Rejection Following Heart Transplantation
Study Start Date : August 2011
Primary Completion Date : October 2015
Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. number and grade of acute allograft rejection episodes [ Time Frame: within one year after transplant surgery ]

Secondary Outcome Measures :
  1. all cause mortality [ Time Frame: one year after transplant surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult heart transplant recipients from recruitment sites (Columbia University-New York Presbyterian Medical Center; University of California, Los Angeles; and Cedars-Sinai Medical Center

Inclusion Criteria:

  • ≥18 years of age
  • first heart transplant surgery
  • not enrolled in other research studies that conflict with study design

Exclusion Criteria:

  • clinically unstable at time of enrollment (i.e. clinical symptoms of allograph impairment)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365806

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095
United States, New York
New York Presbyterian-Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
University of California, Los Angeles
University of California, San Francisco
Cedars-Sinai Medical Center
Columbia University
National Institute of Nursing Research (NINR)
Principal Investigator: Barbara Drew, RN, PhD, FAAN, FAHA University of California, San Francisco
Principal Investigator: Lynn Doering, RN, DNSc University of California, Los Angeles
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Belinda Chen, Project Director, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01365806     History of Changes
Other Study ID Numbers: 1R01NR012003-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017

Keywords provided by Belinda Chen, University of California, Los Angeles:
heart transplantation
allograft rejection
QT interval
electrocardiogram (ECG)