Home Electrocardiogram (ECG) Monitoring After Heart Transplantation (NEW HEART)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, Los Angeles
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: November 30, 2015
Last verified: November 2015
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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:
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 |
| Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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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
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Belinda Chen, Project Director, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01365806 History of Changes |
| Other Study ID Numbers: | 1R01NR012003-01A1 |
| Study First Received: | June 1, 2011 |
| Last Updated: | November 30, 2015 |
| 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 September 26, 2016