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Transcutaneous Electrical Tragus Nerve Stimulation to Reduce Inflammation in Acute Decompensated Heart Failure (NCT02898181)

Acute Decompensated Heart Failure (ADHF) is a major cause of morbidity and mortality. It is associated with increased systemic inflammation. Previous studies have demonstrated increased levels of cytokines such as C-reactive protein (CRP), interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-10 (IL-10) and Tumor Necrosis Factor alpha (TNFα) in patients with heart failure (HF). Increased activity of sympathetic nervous system in ADHF is linked to inflammation. Previous anti-inflammatory drug therapies in HF have demonstrated no significant impact on cardiovascular outcomes. Low-level vagus nerve stimulation (LLVNS) is a non-invasive way to modulate autonomic tone and thereby inflammation. Vagal nerve stimulation is thought to increase the parasympathetic activity and suppress the sympathetic activity. Clinical studies of vagal stimulation in chronic HF have been negative. Recent experimental and clinical data suggest that low level tragus nerve stimulation (LLTNS) may produce the same desired neuromodulator effect compared to LLVNS. It is however unknown if LLTNS in ADHF will directly lead to a reduction in the levels of pro-inflammatory cytokines (CRP, IL-1, IL-6 and TNF-α) and an increase in the level of anti-inflammatory marker IL-10.The objective of this proposal is to determine the impact of LLTS on inflammatory cytokines in patients with ADHF. Patients will be randomized to either active or no stimulation(~8 hours daily). Serum collected will (post admission and on days 2, 3 and 4 post admission) will be used for cytokine measurement. This investigation will likely establish the first evidence of effects of LLTS on suppression of inflammation in patients presenting with ADHF.
  • Device: Tragus nerve stimulation
    Active LLTS will be performed by use of a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to the tragus of the ear.TENS will be applied continuously for 8 hours daily (4 hours twice daily)
    Ages eligible for Study
    18 Years to 75 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Patients admitted with ADHF will undergo echocardiography which is considered standard of care. If estimated LVEF is 40% patients will be enrolled in the study.
    Exclusion Criteria:
    • Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases such as severe aortic or mitral stenosis, severe aortic or mitral regurgitation)
    • Complex congenital heart disease (Tetralogy of Fallot patients, single ventricle physiology)
    • Recurrent vaso-vagal syncopal episodes
    • Unilateral or bilateral vagotomy
    • Sick sinus syndrome
    • 2nd or 3rd degree AV block
    • bifascicular block or prolonged 1st degree AV block (PR>300ms)
    • Pregnant patients
    • Prisoners
    • Advanced renal dysfunction(defined as eGFR < 30, stage 4 or 5 chronic kidney disease)

    1 locations

    United States (1)
    • OUHSC
      recruiting
      Oklahoma City, Oklahoma, United States, 73104
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    31 August, 2016
    Updated:
    07 October, 2017
    Participants:
    80
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