Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure

  • STATUS
    Recruiting
  • days left to enroll
    20
  • participants needed
    50
  • sponsor
    University of Oklahoma
Updated on 28 January 2021

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.

Description

Visit 1: Following tests(to assess vascular function) will be done: 1. FMD 2) LSCI 3) EndoPAT and 4) Pulse wave analysis (PWA). Patients will rest for 10 minutes between each test. They will be trained to use PARASYMTM unit for TVS. Blood collected, serum/plasma will be stored at -80F. Whole blood will be collected in PAXgene tubes. Patients will be instructed to apply TVS to either ear lobule (SHAM) or Tragus(experimental arm). Baseline characteristics will be collected including data on ventricular function(LVEF and left ventricular volumes).

Visit 2 (4 weeks): Follow up tests(FMD,LSCI,EndoPAT,PWA) and repeat blood collection.

Inflammatory cytokines and vascular function assays will be performed.

Details
Condition Heart Failure With Reduced Ejection Fraction
Treatment SHAM, TVS
Clinical Study IdentifierNCT03945058
SponsorUniversity of Oklahoma
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Heart Failure With Reduced Ejection Fraction??
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%

Exclusion Criteria

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
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