Home Electrocardiogram (ECG) Monitoring After Heart Transplantation
This trial has been completed.
|Conditions||cardiac transplant rejection, qt interval, variation in|
|Sponsor||University of California, Los Angeles|
|Collaborator||University of California, San Francisco|
|Start date||August 2011|
|End date||October 2015|
|Trial size||345 participants|
|Trial identifier||NCT01365806, 1R01NR012003-01A1|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Los Angeles, CA||Cedars-Sinai Medical Center||completed|
|Los Angeles, CA||University of California, Los Angeles (UCLA)||completed|
|New York, NY||New York Presbyterian-Columbia University Medical Center||completed|
number and grade of acute allograft rejection episodes
time frame: within one year after transplant surgery
all cause mortality
time frame: one year after transplant surgery
All participants at least 18 years old.
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)
|Official title||Home ECG Monitoring to Detect Allograft Rejection Following Heart Transplantation|
|Principal investigator||Barbara Drew, RN, PhD, FAAN, FAHA|
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