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NCT01365806 · ClinicalTrials.gov registry record
Home Electrocardiogram (ECG) Monitoring After Heart Transplantation
A clinical trial of Cardiac Transplant Rejection and Qt Interval, Variation in, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- 345
- Enrollment target
- 3
- Study locations
NCT01365806 is a study of Cardiac Transplant Rejection and Qt Interval, Variation in that has completed, run by University of California, Los Angeles. The registered enrollment target is 345 participants. The trial reports 3 study locations across 2 states.
The verdict
NCT01365806, a study of Cardiac Transplant Rejection and Qt Interval, Variation in, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- 345 participants
- Enrollment target
- 3
- Study locations
Study 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 Studied
Study Locations (3)
California
- Cedars-Sinai Medical Center - Los Angeles
- University of California, Los Angeles (UCLA) - Los Angeles
New York
- New York Presbyterian-Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01365806
The ClinicalTrials.gov registry entry for NCT01365806 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 345 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cardiac Transplant Rejection appearing as the primary indexed condition, and to 0 interventions.
NCT01365806 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, New York.
Frequently Asked Questions
What is clinical trial NCT01365806 about?
NCT01365806 is a clinical study titled "Home Electrocardiogram (ECG) Monitoring After Heart Transplantation". 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 (E...
What is the current status of trial NCT01365806?
This trial is currently completed. The enrollment target is 345 participants. The study started on 2011-08. Estimated completion is 2016-01.
What conditions does trial NCT01365806 study?
This clinical trial studies the following conditions: Cardiac Transplant Rejection, Qt Interval, Variation in.
Who is sponsoring clinical trial NCT01365806?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01365806 being conducted?
This trial has 3 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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