Clinical trial NCT01365806: Home Electrocardiogram (ECG) Monitoring After Heart Transplantation
Official title: Home ECG Monitoring to Detect Allograft Rejection Following Heart Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Transplant Rejection
Qt Interval, Variation in
Keywords: heart transplantation
allograft rejection
QT interval
electrocardiogram (ECG)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Cedars-Sinai Medical Center
name: Columbia University
name: National Institute of Nursing Research (NINR)
First posted: 2011-06-03
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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)

Primary outcomes:
measure: number and grade of acute allograft rejection episodes
timeFrame: within one year after transplant surgery
Secondary outcomes:
measure: all cause mortality
timeFrame: one year after transplant surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
city: New York
country: United States
facility: New York Presbyterian-Columbia University Medical Center
state: New York
Study officials:
affiliation: University of California, San Francisco
name: Barbara Drew, RN, PhD, FAAN, FAHA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Lynn Doering, RN, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.