Home Electrocardiogram (ECG) Monitoring After Heart Transplantation

NCT01365806 | Completed DMC

• 1 other identifier: 1R01NR012003-01A1
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiac Transplant Rejection; Qt Interval, Variation in

Keywords

heart transplantation; allograft rejection; QT interval; electrocardiogram (ECG)

Outcome Measures

Primary Outcomes (1)

• number and grade of acute allograft rejection episodes

  within one year after transplant surgery

Secondary Outcomes (1)

• all cause mortality

  one year after transplant surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult heart transplant recipients from recruitment sites (Columbia University-New York Presbyterian Medical Center; University of California, Los Angeles; and Cedars-Sinai Medical Center

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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of California, San Francisco: collaborator
• Cedars-Sinai Medical Center: collaborator
• Columbia University: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (3)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

New York Presbyterian-Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Doering LV, Hickey K, Pickham D, Chen B, Drew BJ. Remote noninvasive allograft rejection monitoring for heart transplant recipients: study protocol for the novel evaluation with home electrocardiogram and remote transmission (NEW HEART) study. BMC Cardiovasc Disord. 2012 Mar 2;12:14. doi: 10.1186/1471-2261-12-14.

  PMID: 22386040 DERIVED

Study Officials

• Barbara Drew, RN, PhD, FAAN, FAHA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Lynn Doering, RN, DNSc

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Director

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 3, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 8, 2017

Record last verified: 2017-03

Locations

US (3)