Low Level Tragus Stimulation in Acute Decompensated Heart Failure

Launched by UNIVERSITY OF OKLAHOMA · Sep 7, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called low-level tragus nerve stimulation (LLTNS) for patients with acute decompensated heart failure (ADHF). ADHF is a serious condition where the heart cannot pump blood effectively, leading to symptoms like shortness of breath and swelling. The trial aims to see if LLTNS can help reduce inflammation in the body, improve heart function, and make patients feel better during their hospital stay. Participants will be divided into two groups: one will receive the active treatment while the other will receive a placebo (a fake treatment). They will have their blood tested and heart activity monitored to track changes.

To be eligible for this trial, patients must be admitted to the hospital with ADHF. However, some individuals may not qualify, such as those with certain heart conditions, advanced kidney disease, or infections like hepatitis C or HIV. Throughout the study, participants can expect to spend about two hours each day receiving the treatment, and their health will be closely monitored to understand how LLTNS affects their condition. This trial could provide important insights into a new way to help manage heart failure and improve patients' quality of life.

Gender

ALL

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. Advanced renal dysfunction(defined as eGFR \< 30, stage 4 or 5 chronic kidney disease)
• • 11. Hepatitis C or HIV
• • 12. Acute Myocardial infarction