What side effects are associated with this type of intervention?

Common treatments for heart failure, particularly those involving neuromodulation like Low-Level Tragus Nerve Stimulation (LLTNS), generally aim to modulate autonomic tone and reduce inflammation. Known side effects of such treatments are typically mild and may include sensations such as warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas like the arm, shoulder, or neck. Serious adverse events are rare. These treatments are considered relatively safe, but ongoing monitoring and further studies are needed to fully understand their long-term safety profiles.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that focus on different mechanisms, including pharmacologic agents and device-based therapies. While traditional pharmacologic treatments like beta-blockers, ACE inhibitors, and ARBs focus on managing symptoms and improving heart function, device-based therapies such as cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillators (ICDs) aim to improve heart rhythm and prevent sudden cardiac death. However, specific treatments that modulate autonomic tone to reduce inflammation, similar to Low-Level Tragus Nerve Stimulation (LLTNS), are still under investigation and have not yet been widely approved by the FDA for heart failure.

What other types of research exist?

Promising novel alternatives to LLTNS for heart failure patients include: 1) Vagal Nerve Stimulation (VNS), which similarly aims to modulate autonomic tone and reduce inflammation. 2) Spinal Cord Stimulation (SCS), which has shown potential in managing chronic pain and could be explored for heart failure-related symptoms. 3) Emerging pharmacological treatments targeting specific inflammatory pathways, such as IL-1 and IL-6 inhibitors, which are under investigation for their potential to reduce systemic inflammation in heart failure patients.

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Behavioural Intervention

Neuromodulation for Heart Failure (TREAT-HF Trial)

N/A

Recruiting

Led By Tarun Dasari, MD,MPH

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients admitted with ADHF

Be older than 18 years old

Must not have

Unilateral or bilateral vagotomy

Hepatitis C or HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from admission to discharge- over average 3-6 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment that stimulates a part of the ear to help calm the body's stress responses and reduce inflammation in patients with severe heart failure. The goal is to see if this can improve their heart function and overall health.

Who is the study for?

This trial is for patients admitted with Acute Decompensated Heart Failure (ADHF). It's not suitable for those who refuse consent, have complex heart conditions like Tetralogy of Fallot, history of frequent fainting due to low heart rate or blood pressure, major nerve surgery in the neck, severe heartbeat irregularities, are pregnant or imprisoned, and those with advanced kidney disease or certain infections like Hepatitis C or HIV.

What is being tested?

The study tests if Low Level Tragus Stimulation (LLTS), a non-invasive technique that affects nerve activity related to the heart can reduce inflammation markers in the blood and improve symptoms such as difficulty breathing. Participants will be randomly assigned to receive either real LLTS or a sham treatment daily during their hospital stay.

What are the potential side effects?

Since LLTS is non-invasive and involves stimulating nerves on the outer ear, side effects might include local discomfort at the stimulation site. However, because it influences nervous system activity related to heart function there may be risks of affecting heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was admitted to the hospital for acute decompensated heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery to cut the nerves to my stomach.

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I have Hepatitis C or HIV.

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I have been diagnosed with sick sinus syndrome.

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I have had a heart attack recently.

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My kidney function is severely reduced.

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I do not agree to participate in the study.

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I have had multiple fainting spells due to sudden drops in heart rate and blood pressure.

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I have a complex heart condition from birth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from admission to discharge- over average 3-6 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from admission to discharge- over average 3-6 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from admission to discharge- over average 3-6 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in CRP levels

Change in Interleukin (IL) levels

Change in Pro BNP and renal function(creatinine) levels

+1 more

Secondary study objectives

Change in HRV

Other study objectives

Change in level of dyspnea

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tragus StimulationExperimental Treatment1 Intervention

In this group patients will receive neuromodulation for 2 hours daily

Group II: Control groupActive Control1 Intervention

Sham neuromodulation will be done

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neuromodulation

2022

Completed Phase 4

~70

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart failure often aim to modulate autonomic tone and reduce inflammation, which is crucial for improving patient outcomes. Low-Level Tragus Nerve Stimulation (LLTNS) works by increasing parasympathetic activity and suppressing sympathetic activity, thereby reducing systemic inflammation and improving heart function. This is similar to other neuromodulation techniques like vagus nerve stimulation, which also aim to balance autonomic nervous system activity. Additionally, standard treatments such as ACE inhibitors, beta-blockers, and diuretics work by reducing the workload on the heart, controlling blood pressure, and managing fluid retention. These mechanisms are vital for heart failure patients as they help to alleviate symptoms, improve quality of life, and reduce the risk of hospitalization and mortality.