Home Electrocardiogram (ECG) Monitoring After Heart Transplantation (NEW HEART)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

University of California, San Francisco

Cedars-Sinai Medical Center

Columbia University

National Institute of Nursing Research (NINR)

Information provided by (Responsible Party):

Belinda Chen, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT01365806

First received: June 1, 2011

Last updated: December 1, 2014

Last verified: December 2014

History of Changes

Purpose

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.

Condition
Cardiac Transplant Rejection Qt Interval, Variation in


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Home ECG Monitoring to Detect Allograft Rejection Following Heart Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Heart Transplantation

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

number and grade of acute allograft rejection episodes [ Time Frame: within one year after transplant surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

all cause mortality [ Time Frame: one year after transplant surgery ] [ Designated as safety issue: No ]


Estimated Enrollment:	400
Study Start Date:	August 2011
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365806

Locations


United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095
United States, New York
New York Presbyterian-Columbia University Medical Center
New York, New York, United States, 10032

Sponsors and Collaborators

University of California, Los Angeles

University of California, San Francisco

Cedars-Sinai Medical Center

Columbia University

National Institute of Nursing Research (NINR)

Investigators


Principal Investigator:	Barbara Drew, RN, PhD, FAAN, FAHA	University of California, San Francisco
Principal Investigator:	Lynn Doering, RN, DNSc	University of California, Los Angeles

More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Belinda Chen, Project Director, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT01365806 History of Changes
Other Study ID Numbers:	1R01NR012003-01A1, 1R01NR012003-01A1
Study First Received:	June 1, 2011
Last Updated:	December 1, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:


heart transplantation allograft rejection QT interval electrocardiogram (ECG)

ClinicalTrials.gov processed this record on March 03, 2015

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