Home Electrocardiogram (ECG) Monitoring After Heart Transplantation

Qt Interval, Variation in Clinical Trial

— NEW HEART  

Official title:

Home ECG Monitoring to Detect Allograft Rejection Following Heart Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365806
• Other study ID #: 1R01NR012003-01A1
• Secondary ID: 1R01NR012003-01A
• Status: Completed
• Phase: N/A
• First received: June 1, 2011
• Last updated: March 6, 2017
• Start date: August 2011
• Est. completion date: January 2016

Study information

• Verified date: March 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Transplant Rejection
• Qt Interval, Variation in

Locations

Country	Name	City	State
United States	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

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Los Angeles	Cedars-Sinai Medical Center, Columbia University, National Institute of Nursing Research (NINR), University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number and grade of acute allograft rejection episodes		within one year after transplant surgery
Secondary	all cause mortality		one year after transplant surgery