Stopped: Study was unable to meet target enrollment; no results generated.
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.
Age range
18 Years – 85 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Flow Mediated Dilation (FMD)
Timeframe: Change in the brachial artery diameter will be compared to baseline change after 4 weeks of TVS or sham.
Laser Speckle Contrast Imaging (LSCI)
Timeframe: Change in the perfusion units will be determined at baseline and after 4 weeks of TVS or sham stimulation.
EndoPAT
Timeframe: Change in the reactive hyperemia index from baseline and after 4 weeks of TVS or SHAM stimulation
Pulse Wave Analysis (PWA)
Timeframe: Change in the augmentation index will be calculated at baseline and after 4 weeks of TVS or sham stimulation.
Biomarkers of inflammation
Timeframe: Change in these biomarkers(% change) over 4 weeks will be calculated.
Biomarkers of endothelial function and oxidative stress
Timeframe: Change in these biomarkers(%) over 4 weeks will be calculated.