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Home Electrocardiogram (ECG) Monitoring After Heart Transplantation
NCT01365806 · View on ClinicalTrials.gov ↗
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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 829 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cardiac Transplant Rejection appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01365806 reports 3 study locations spanning 2 distinct geographic areas — top geographies include California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01365806?
This trial is sponsored by University of California, Los Angeles, which has 829 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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