Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure

Stopped early · Not applicable · Has a placebo group

Conditions studied: Heart Failure With Reduced Ejection Fraction

In brief

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.

Key facts

Study ID

NCT03945058

Run by

University of Oklahoma

People needed

7

Starts

2020-02-04

Expected to finish

2021-12-16

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients (18 years or older) with Heart failure with reduced ejection fraction (HFrEF), which is a history of symptomatic heart failure with left ventricular ejection fraction (LVEF) of < 40%.

You may not qualify if…

• Patients in overt congestive heart failure / recent acute myocardial infarction (< 3 months) or Unstable angina
• Active malignancy
• Pre-menopausal women and post-menopausal women on hormone supplements.
• Unilateral or bilateral vagotomy
• Patients with bilateral upper extremity amputation
• Pregnant patients
• End-stage renal disease
• End-stage liver disease
• History of recurrent vasovagal syncope, Sick sinus syndrome, 2nd- or 3rd-degree atrioventricular (AV) block.
• Patients with clinically documented upper extremity arterial disease
• Patients with a body mass index (BMI) >35
• Significant hypotension (blood pressure <90mmHg) secondary to autonomic dysfunction

Where it is running

• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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