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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
Sponsor:
Collaborators:
University of California, San Francisco
Cedars-Sinai Medical Center
Columbia University
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Belinda Chen, University of California, Los Angeles

June 1, 2011
June 3, 2011
March 8, 2017
August 2011
October 2015   (Final data collection date for primary outcome measure)
number and grade of acute allograft rejection episodes [ Time Frame: within one year after transplant surgery ]
Same as current
Complete list of historical versions of study NCT01365806 on ClinicalTrials.gov Archive Site
all cause mortality [ Time Frame: one year after transplant surgery ]
Same as current
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Home Electrocardiogram (ECG) Monitoring After Heart Transplantation
Home ECG Monitoring to Detect Allograft Rejection Following Heart Transplantation
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
adult heart transplant recipients from recruitment sites (Columbia University-New York Presbyterian Medical Center; University of California, Los Angeles; and Cedars-Sinai Medical Center
  • Cardiac Transplant Rejection
  • Qt Interval, Variation in
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Doering LV, Hickey K, Pickham D, Chen B, Drew BJ. Remote noninvasive allograft rejection monitoring for heart transplant recipients: study protocol for the novel evaluation with home electrocardiogram and remote transmission (NEW HEART) study. BMC Cardiovasc Disord. 2012 Mar 2;12:14. doi: 10.1186/1471-2261-12-14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
400
January 2016
October 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01365806
1R01NR012003-01A1( U.S. NIH Grant/Contract )
1R01NR012003-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Belinda Chen, University of California, Los Angeles
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
University of California, Los Angeles
March 2017