Home Electrocardiogram (ECG) Monitoring After Heart Transplantation

Completed

• Conditions: Cardiac Transplant Rejection; Qt Interval, Variation in

• Registration Number: NCT01365806
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Study Start: 2011-08
• Primary Completion: 2015-10
• Study Completion: 2016-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number and grade of acute allograft rejection episodes	within one year after transplant surgery

Secondary Outcome Measures

Name	Time	Method
all cause mortality	one year after transplant surgery

Trial Locations

Locations (3)

University of California, Los Angeles (UCLA); 🇺🇸 Los Angeles, California, United States

New York Presbyterian-Columbia University Medical Center; 🇺🇸 New York, New York, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States