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

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

number and grade of acute allograft rejection episodes
time frame: within one year after transplant surgery

Secondary Outcomes

all cause mortality
time frame: one year after transplant surgery

Eligibility Criteria

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)

Additional Information

Official title Home ECG Monitoring to Detect Allograft Rejection Following Heart Transplantation
Principal investigator Barbara Drew, RN, PhD, FAAN, FAHA
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.