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NCT03945058 · ClinicalTrials.gov registry record · NA
Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure
A NA study, sponsored by University of Oklahoma.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT03945058 is a NA study that was terminated before completion, run by University of Oklahoma. The registered enrollment target is 7 participants.
The verdict
NCT03945058, a NA study, was terminated before completion, sponsored by University of Oklahoma.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
Heart failure (HF) is the leading cause of death in US. It is associated with abnormal vascular function termed endothelial dysfunction. It is also associated with increased stress on the blood vessels and high levels of inflammation. Vagus nerve stimulation can help improve inflammation, vascular function and vascular stress. The investigator has recently completed a study showing that 1 hour of noninvasive vagus stimulation can improve vascular health. However, it is unknown if 4 weeks of stimulation will be beneficial in systolic heart failure. The purpose of this study is to determine if transcutaneous vagal stimulation (TVS) will lead to improvement in the function of the inner lining of participants' arteries, memory, and in the levels of certain chemical markers of arterial function in the blood. Participants will be randomized to receive either TVS or a sham stimulation and undergo 4 weeks of stimulation. Vascular function will be assessed by several non-invasive measurements, including Flow Mediate Dilation (FMD), Pulse Wave Analysis (PWA), EndoPAT, and Laser Speckle Contrast Imaging (LSCI). Participants' memory will also be measured through electronic assessments and blood will be collected and analyzed for arterial function chemical markers.
Interventions
- DEVICE SHAM
- DEVICE TVS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2021-12-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03945058
The ClinicalTrials.gov registry entry for NCT03945058 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SHAM is the first listed.
NCT03945058 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03945058 about?
NCT03945058 is a clinical study titled "Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure". Heart failure (HF) is the leading cause of death in US. It is associated with abnormal vascular function termed endothelial dysfunction. It is also associated with increased stress on the blood vessels and high levels of inflammation. Vagus nerve stimulation can help improve inflammation, vascular f...
What is the current status of trial NCT03945058?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2020-02-04. Estimated completion is 2021-12-16.
What interventions are being tested in trial NCT03945058?
The interventions under investigation include: SHAM (DEVICE), TVS (DEVICE).
Who is sponsoring clinical trial NCT03945058?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
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