RecruitingNot ApplicableNCT05230732

Neuromodulation of Inflammation and Endothelial Function

Neuromodulation of Inflammation and Endothelial Function to Treat Elderly Patients With Systolic Heart Failure


Sponsor

University of Oklahoma

Enrollment

158 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether stimulating the vagus nerve (a major nerve that runs from the brain to the abdomen and helps regulate inflammation and heart function) can reduce inflammation and improve blood vessel function in patients with heart failure. **You may be eligible if...** - You have been diagnosed with systolic heart failure (where the heart does not pump strongly enough), with an ejection fraction of 50% or less - You are stable enough to participate in a procedure **You may NOT be eligible if...** - You are currently in acute (severe, active) heart failure - You had a heart attack within the last 4 weeks - You have unstable angina (chest pain at rest) - You have active cancer - You have had prior surgery to cut the vagus nerve - You are pregnant - You have end-stage liver disease or a history of recurrent fainting Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEneuromodulation device

Active LLTS will be performed by use of a neuromodulation device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour daily for 12 weeks

DEVICESHAM

Sham LLTS will be performed by use of a neuromodulation device with electrodes attached to the ear lobule. Stimulator will be applied continuously for 1 hour daily for 12 weeks


Locations(1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

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NCT05230732


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