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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: Clinical Trial NA study, sponsored by University of Oklahoma.
NCT03945058 is a NA study that was terminated before completion, run by University of Oklahoma. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
FMD is a change in the maximal diameter of the brachial artery. Brachial artery diameter (in millimeters) will be assessed before and after 4 weeks of stimulation using standard ultrasound.
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 |
Why NCT03945058 stopped before completion
NCT03945058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which SHAM is the first listed.
NCT03945058 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03945058's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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