Low Level Tragus Stimulation in Acute Decompensated Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuromodulation.
- Who it may be relevant to
- Registry conditions: Acute Decompensated Heart Failure. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Low Level Transcutaneous Tragus Stimulation to Reduce Inflammation, Dyspnea and Improve Heart Rate Variability in Acute Decompensated Heart Failure
Overview
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. heart rate variability may also be abnormal in ADHF. The objective of this proposal is to determine the impact of LLTS on inflammatory cytokines, heart failure biomarkers(Pro BNP) and HRV in patients with ADHF.In addition we will study the impact on dyspnea resolution and change in renal function during hospitalization. Patients will be randomized to either active or sham stimulation (2 hours daily). Serum collected will (post-admission and discharge day) will be used for cytokine measurement. We will also measure daily ECG to assess HRV and patient assessed dyspnea scale.This investigation will likely establish the first evidence of the effects of LLTS on the suppression of inflammation and improvement in dyspnea, natriuretic peptides, renal function and HRV in patients presenting with ADHF.
Detailed description
Acute Decompensated Heart Failure (ADHF) is a major cause of morbidity and mortality. It is associated with increased systemic inflammation and poor outcomes.
Previous studies have demonstrated increased inflammation 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 via stimulation of teh Tragus (LLTS) 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. Recent experimental and clinical data suggest that low level tragus nerve stimulation (LLTS) may produce the same desired neuromodulator effect compared to LLVNS.
It is however unknown if LLTS in ADHF will directly lead to sympathetic tone reduction and increase in parasympathetic tone, or neuromodulation and lead to 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.
Autonomic tone could be assessed using heart rate variability. The objective of this proposal is to determine the impact of LLTS on inflammatory cytokines and HRV in patients with ADHF.
Patients will be randomized to either active or sham stimulation (2 hours daily).
Serum collected will (post admission and discharge day) will be used for cytokine and biomarker measurement. We will also measure 10-15 minute ECG to assess HRV. Dyspnea will be determined using patient assessment tool(visual analog scale).This investigation will likely establish the first evidence of effects of LLTS on suppression of inflammation and improvement in dyspnea scale, renal function and HRV in patients presenting with ADHF.
Interventions
- Device Neuromodulation
Active LLTS will be performed by use of a transcutaneous electrical nerve stimulation Parasym neuromodulation system with electrodes attached to the ear. Neuromodulation will be applied continuously for 2 hours daily.
Primary outcome measures
- Change in Interleukin (IL) levels [Time frame: From admission to discharge- over average 3-6 days]
- Change in TNF-alpha levels [Time frame: From admission to discharge- over average 3-6 days]
- Change in CRP levels [Time frame: From admission to discharge- over average 3-6 days]
- Change in Pro BNP and renal function(creatinine) levels [Time frame: From admission to discharge- over average 3-6 days]
Secondary outcome measures (1)
- Change in HRV [Time frame: From admission to discharge- over average 3-6 days]
Eligibility criteria
Inclusion criteria
Patients admitted with ADHF
Exclusion criteria
- Refusal to consent
- 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)
- Hepatitis C or HIV
- Acute Myocardial infarction
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- OUHSC — Oklahoma City
Publications
- Dasari TW, Chakraborty P, Mukli P, Akhtar K, Yabluchanskiy A, Cunningham MW, Csiszar A, Po SS. Noninvasive low-level tragus stimulation attenuates inflammation and oxidative stress in acute heart failure. Clin Auton Res. 2023 Dec;33(6):767-775. doi: 10.1007/s10286-023-00997-z. Epub 2023 Nov 9. PMID 37943335
- Dasari T, Chakraborty P, Mukli P, Akhtar K, Yabluchanskiy A, Cunningham MW, Csiszar A, Po SS. Noninvasive low-level tragus stimulation attenuates inflammation and oxidative stress in acute heart failure. Res Sq [Preprint]. 2023 Sep 11:rs.3.rs-3323086. doi: 10.21203/rs.3.rs-3323086/v1. PMID 37790298
Identifiers
NCT: NCT02898181 · 6778