NCT02898181 Low Level Tragus Stimulation in Acute Decompensated Heart Failure
| NCT ID | NCT02898181 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oklahoma |
| Condition | Acute Decompensated Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2016-09 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2016-09 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Tarun Dasari, MD,MPH
PRINCIPAL INVESTIGATOR
OUHSC
Frequently Asked Questions
Who can join the NCT02898181 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Decompensated Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02898181 currently recruiting?
Yes, NCT02898181 is actively recruiting participants. Contact the research team at tdasari@ouhsc.edu for enrollment information.
Where is the NCT02898181 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT02898181 clinical trial?
NCT02898181 is sponsored by University of Oklahoma. The principal investigator is Tarun Dasari, MD,MPH at OUHSC. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.