Home Electrocardiogram (ECG) Monitoring After Heart Transplantation
Completed
Conditions studied: Cardiac Transplant Rejection, Qt Interval, Variation in
In brief
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.
Key facts
- Study ID
- NCT01365806
- Run by
- University of California, Los Angeles
- People needed
- 345
- Starts
- 2011-08-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2017-03-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥18 years of age
- first heart transplant surgery
- not enrolled in other research studies that conflict with study design
You may not qualify if…
- clinically unstable at time of enrollment (i.e. clinical symptoms of allograph impairment)
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- University of California, Los Angeles (UCLA) — Los Angeles, California, United States
- New York Presbyterian-Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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