Neuromodulation Therapy for Heart Failure
Trial Summary
What is the purpose of this trial?
Heart failure with reduced ejection fraction (HFrEF) is a major cause of mortality in United States. Aging is a major risk factor for adverse outcomes associated with HFrEF, with majority of the patient's over the age of 50, continuing to experience symptoms, reduced exercise capacity and poor quality of life. We have previously demonstrated that low level transcutaneous electrical stimulation of the vagus nerve at the tragus (LLTS) suppresses inflammation in patients with atrial fibrillation and diastolic dysfunction and improved endothelial dysfunction in patients with chronic heart failure. The overall objective of this proposal is to examine the effects of LLTS on heart failure symptoms, exercise capacity and quality of life in patients with HFrEF and simultaneously determine the impact of LLTS on the suppression of inflammation and improvement in endothelial function. Our specific aims include: 1. To examine the medium term effect of intermittent (1 hour daily for 3 months) LLTS on exercise capacity and quality of life, related to sham stimulation, in patients with HFrEF, 2. To determine the effects of medium-term LLTS on sympathovagal/autonomic balance (assessed by heart rate variability) and systemic inflammation in patients with HFrEF and 3. To determine the effects of medium-term LLTS on endothelial function in patients with HFrEF. The proposed proof-of-concept human studies will provide the basis for the design of further human studies using LLTS among larger populations with HFrEF. In light of the increasing number of elderly patients who continue to experience HFrEF symptoms, recognized is a key point of interest in this funding mechanism, and the suboptimal success of the currently available treatment options to ameliorate the problems mentioned above, an alternative novel approach such as LLTS has the potential to impact clinical practice and improve health outcomes among the large number of patients. It is anticipated that these investigations will contribute to a broader understanding of the role of autonomic imbalance, inflammation and endothelial dysfunction in the pathogenesis of HFrEF and how its inhibition can be used to provide therapeutic effects. Moreover, it is anticipated that a better understanding of how modulation of autonomic tone, inflammation and endothelial function affects one of the hallmarks of HFrEF will lead to the development of normal nonpharmacological and pharmacological approaches to treat this disease.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the treatment SHAM, Tragus Stimulator for heart failure?
Research shows that low-level tragus stimulation (LLTS) can help improve heart function by reducing inflammation and stress in heart failure patients. It has also shown promise in treating other heart-related issues like arrhythmias and heart attacks, suggesting it could be beneficial for heart failure.12345
Is neuromodulation therapy for heart failure safe for humans?
Neuromodulation therapy, like low-level tragus stimulation (LLTS) and transcutaneous auricular vagus nerve stimulation (taVNS), is generally considered safe in humans. Most studies report only mild and temporary side effects such as ear pain, headache, and tingling, with no severe adverse events linked to the treatment.23567
How does the Tragus Stimulator treatment for heart failure differ from other treatments?
The Tragus Stimulator is unique because it is a non-invasive treatment that uses low-level stimulation of the tragus (a part of the ear) to modulate the nervous system, aiming to restore balance between the sympathetic and parasympathetic systems. This approach is different from traditional heart failure treatments, which often involve medications or invasive procedures, as it targets the neuro-immune axis to reduce inflammation and oxidative stress.23489
Research Team
Tarun Dasari, MD, MPH
Principal Investigator
University of Oklahoma
Eligibility Criteria
This trial is for adults with heart failure where the heart's pumping ability is reduced (EF ≤ 50%). It's not suitable for pregnant individuals, those with severe liver disease, recent heart attacks or unstable angina, active cancer, certain nerve surgeries (vagotomy), frequent fainting due to low blood pressure, specific irregular heartbeat conditions without a pacemaker, or dangerously low blood pressure from autonomic dysfunction.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active or sham LLTS for 1 hour daily over 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- SHAM
- Tragus Stimulator
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
National Institutes of Health (NIH)
Collaborator