Neuromodulation for Heart Failure
(TREAT-HF Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Oklahoma
Disqualifiers: Congenital heart disease, Vagotomy, AV block, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
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's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment for heart failure?
Is low-level tragus stimulation safe for humans?
Low-level tragus stimulation (LLTS) has been studied in humans for various conditions, including heart failure and epilepsy, and is generally considered safe. Studies have shown it can be used without significant discomfort or adverse effects, as it is a non-invasive method that stimulates the vagus nerve through the skin.12345
How is tragus stimulation treatment different from other heart failure treatments?
Tragus stimulation is a unique, non-invasive treatment that uses low-level electrical impulses to stimulate the vagus nerve through the ear, which can help improve heart function by balancing the nervous system's control over the heart. Unlike traditional heart failure treatments that often involve medications or invasive procedures, this approach targets the body's natural nerve pathways to potentially reduce heart strain and improve heart health.12356
Eligibility Criteria
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.Inclusion Criteria
I was admitted to the hospital for acute decompensated heart failure.
Exclusion Criteria
I have had surgery to cut the nerves to my stomach.
I have Hepatitis C or HIV.
You have a specific type of heart block called 2nd or 3rd degree AV block.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
Treatment
Participants receive either active or sham tragus stimulation for 2 hours daily
3-6 days
Daily visits during hospitalization
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Tragus Stimulation (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
OUHSCOklahoma City, OK
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Who Is Running the Clinical Trial?
University of OklahomaLead Sponsor
References
Non-invasive Low-level Tragus Stimulation in Cardiovascular Diseases. [2020]Low-level tragus stimulation (LLTS) is a non-invasive approach of transcutaneous vagus nerve stimulation. LLTS has applications in diseases of multiple systems, including epilepsy, depression, headache and potentially several cardiovascular diseases. LLTS has shown promising results in suppressing AF, alleviating post-MI ventricular arrhythmias and ischaemia-reperfusion injury along with improving diastolic parameters in heart failure with preserved left ventricular ejection fraction (HFpEF). Preliminary pilot clinical studies in patients with paroxysmal AF, HFpEF, heart failure with reduced ejection fraction and acute MI have demonstrated promising results. The beneficial effects are likely secondary to favourable alteration of the sympathovagal imbalance. On-going exploratory work focused on underlying mechanisms of LLTS in cardiovascular disease states and larger scale clinical trials will shed more light on the non-invasive modulation of the neuro-immune axis.
Autonomic Neuromodulation Acutely Ameliorates Left Ventricular Strain in Humans. [2020]Low-level transcutaneous vagus nerve stimulation at the tragus (LLTS) is anti-adrenergic. We aimed to evaluate the acute effects of LLTS on left ventricular (LV) function and autonomic tone. Patients with diastolic dysfunction and preserved LV ejection fraction were enrolled in a prospective, randomized, double-blind, 2 × 2 cross-over study. Patients received two separate, 1-h sessions, at least 1 day apart, of active LLTS (20 Hz, 1 mA below the discomfort threshold) and sham stimulation. Echocardiography was performed after LLTS or sham stimulation to assess cardiac function. A 5-min ECG was performed to assess heart rate variability (HRV). Twenty-four patients were enrolled. LV global longitudinal strain improved by 1.8 ± 0.9% during active LLTS compared to sham stimulation (p = 0.001). Relative to baseline, HRV frequency domain components (low frequency, high frequency, and their ratio) were favorably altered after LLTS compared to sham stimulation (all p
Chronic intermittent low-level transcutaneous electrical stimulation of auricular branch of vagus nerve improves left ventricular remodeling in conscious dogs with healed myocardial infarction. [2014]Vagus nerve stimulation attenuates left ventricular (LV) remodeling after myocardial infarction (MI). Our previous study found a noninvasive approach to deliver vagus nerve stimulation by transcutaneous electric stimulation of auricular branch of vagus nerve. So we hypothesize that chronic intermittent low-level tragus stimulation (LL-TS) could attenuate LV remodeling in conscious dogs with healed MI.
Insights Into the Effects of Low-Level Vagus Nerve Stimulation on Atrial Electrophysiology: Towards Patient-Tailored Cardiac Neuromodulation. [2023]Low-level vagus nerve stimulation through the tragus (tLLVNS) is increasingly acknowledged as a therapeutic strategy to prevent and treat atrial fibrillation. However, a lack in understanding of the exact antiarrhythmic properties of tLLVNS has hampered clinical implementation.
Microvolt T-Wave Alternans Is Modulated by Acute Low-Level Tragus Stimulation in Patients With Ischemic Cardiomyopathy and Heart Failure. [2021]Aims: Microvolt T-wave alternans (TWA), an oscillation in T-wave morphology of the electrocardiogram (ECG), has been associated with increased susceptibility to ventricular tachy-arrhythmias, while vagus nerve stimulation has shown promising anti-arrhythmic effects in in vivo and ex vivo animal studies. We aimed to examine the effect of non-invasive, acute low-level tragus stimulation (LLTS) on TWA in patients with ischemic cardiomyopathy and heart failure. Methods: 26 patients with ischemic cardiomyopathy (left ventricular ejection fraction <35%) and chronic stable heart failure, previously implanted with an automatic implantable cardioverter defibrillator (ICD) device with an atrial lead (dual chamber ICD or cardiac resynchronization therapy defibrillator), were enrolled in the study. Each patient sequentially received, (1) Sham LLTS (electrode on tragus, but no stimulation delivered) for 5 min; (2) Active LLTS at two different frequencies (5 and 20 Hz, 15 min each); and (3) Active LLTS, during concomitant atrial pacing at 100 bpm at two different frequencies (5 and 20 Hz, 15 min each). LLTS was delivered through a transcutaneous electrical nerve stimulation device (pulse width 200 μs, frequency 5/20 Hz, amplitude 1 mA lower than the discomfort threshold). TWA burden was assessed using continuous ECG monitoring during sham and active LLTS in sinus rhythm, as well as during atrial pacing. Results: Right atrial pacing at 100 bpm led to significantly heightened TWA burden compared to sinus rhythm, with or without LLTS. Acute LLTS at both 5 and 20 Hz, during sinus rhythm led to a significant rise in TWA burden in the precordial leads (p < 0.05). Conclusion: Acute LLTS results in a heart-rate dependent increase in TWA burden.
Non-invasive tragus stimulation improves cardiac post-ischemic remodeling by regulating cardiac parasympathetic activity. [2023]Our previous study proved that low-level tragus nerve stimulation (LL-TS) could improve left ventricular remodelling by cardiac down-stream mechanisms. However, the cardiac up-stream mechanisms remain unknown.