Non-invasive stimulation of the tragus to reduce inflammation in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of low-level tragus nerve stimulation (LLTS) on patients with acute decompensated heart failure (ADHF), a condition characterized by increased systemic inflammation and poor outcomes. Patients will be randomized to receive either active or sham stimulation for two hours daily, with the aim of assessing changes in inflammatory cytokines and heart rate variability. The study seeks to determine whether LLTS can effectively modulate autonomic tone and reduce inflammation in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Ouhsc
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Tarun Dasari, MD,MPH — Ouhsc
• Study coordinator: Tarun Dasari, MD,MPH
• Email: tarun-dasari@ou.edu
• Phone: 4052714742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.