RightFit
RecruitingNot applicable

Low Level Tragus Stimulation in Acute Decompensated Heart Failure

Low Level Transcutaneous Tragus Stimulation to Reduce Inflammation, Dyspnea and Improve Heart Rate Variability in Acute Decompensated Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "We will also measure 10-15 minute ECG to assess HRV."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people in the hospital with heart failure that has suddenly gotten worse. It tests whether gentle nerve stimulation at the tragus, the small flap near the ear opening, changes inflammation, heart function markers, breathing, or kidney function. Patients will be assigned by chance to real or sham (inactive) stimulation for 2 hours each day.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • In the hospital with heart failure that has suddenly gotten worse.

Who can't join

  • Do not agree to join the study.
  • Have a complex heart defect present at birth, such as tetralogy of Fallot or a heart with only one working pumping chamber.
  • Have repeated fainting spells caused by sudden drops in heart rate or blood pressure.
  • Have had surgery to cut the vagus nerve on one or both sides of the body.
  • Have certain heart rhythm or electrical signal problems: sick sinus syndrome, second- or third-degree AV block, bifascicular block, or first-degree AV block with a PR interval over 300 milliseconds.
  • Are pregnant or a prisoner.
  • Have kidney failure that requires dialysis, a treatment that filters the blood.
  • Are having a heart attack.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Patients admitted with ADHF Exclusion Criteria: 1. Refusal to consent 2. Complex congenital heart disease (Tetralogy of Fallot patients, single ventricle physiology) 3. Recurrent vaso-vagal syncopal episodes 4. Unilateral or bilateral vagotomy 5. Sick sinus syndrome 6. 2nd or 3rd degree AV block 7. bifascicular block or prolonged 1st degree AV block (PR\>300ms) 8. Pregnant patients 9. Prisoners 10. End stage renal disease on dialysis 11. Acute Myocardial infarction

Study sites (1)

OK