Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

• Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center (U.S. Fed)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06110364
• Collaborator: Virginia Commonwealth University (Other)
• Enrollment: 20
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Prospective randomized control pilot study

Condition or Disease	Intervention/Treatment	Phase
Premature Ventricular Contraction	Device: Low-Level Tragus Stimulation; Behavioral: Heart Rate Variability- Biofeedback; Other: Conventional Medical Therapy	Phase 3

Detailed Description

The primary aims of this investigator initiated study is :

Aim 1: to assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions and Aim 2: to compare the efficacy of Lower-level Tragus stimulation and Heart rate variability- Biofeedback in suppression of Premature Ventricular Contractions.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Patients will be randomized to Premature ventricular contraction suppression strategies: 1) Lower level tragus stimulation 2) Heart rate variability biofeedback and 3) conventional medical therapy (usual care.)Patients will be randomized to Premature ventricular contraction suppression strategies: 1) Lower level tragus stimulation 2) Heart rate variability biofeedback and 3) conventional medical therapy (usual care.)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-Level Tragus Stimulation The Low-Level Tragus Stimulation will be done with TENS.	Device: Low-Level Tragus Stimulation; Low-Level Tragus Stimulation via TENS unit will be monitored with a Holter.; Other Names: TENS
Experimental: Heart Rate Variability- Biofeedback Heart Rate Variability-Biofeedback will be done with a phone application. Practice sessions are at least 10-15 minutes twice a daily.	Behavioral: Heart Rate Variability- Biofeedback; Heart Rate Variability- Biofeedback will be monitored with a Holter.; Other Names: Breathing Exercises / Inner Balance
Active Comparator: Conventional Medical Therapy Subjects without beta blockers will be initiated on a usual/standard care medication of beta blockers to determine the efficacy of this standard medication therapy for Premature Ventricular Contraction suppression.	Other: Conventional Medical Therapy; Conventional Medical Therapy by Beta Blockers will be added to subjects usual care by their doctor if they are not already taking this medication.; Other Names: Usual care medication

Outcome Measures

Primary Outcome Measures

1. Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions. [perspective 12-week study (each arm lasting two weeks with a one week washout between each arm)]

   Compare the effects of Premature Ventricular Contractions suppression between standard medical therapy and non-invasive vagal nerve stimulation.

Secondary Outcome Measures

1. Compare the efficacy of non-invasive vagal nerve stimulation via lower-level vagal stimulation and heart rate variability in suppression of Premature Ventricular Contractions. [perspective 12-week study (each arm lasting two weeks with a one-week washout between each arm)]

   It is speculated that Heart Rate Variability-Biofeedback is as effective as Lower Level Tragus Stimulation to achieve successful Premature Ventricular Contraction suppression.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Normal Left Ventricular systolic function

• Frequent PVCs

Exclusion Criteria:

• Current use of any (I and/or III) antiarrhythmic medication

• Contraindication to use beta blockers and non-dihydropyridine calcium channel blockers

• Complete Atrioventricular block and pacemaker dependent

• Ongoing uncontrolled hypertension with systolic Blood Pressure> 180

• Family history of dilated Cardiomyopathy in a first degree relative

• Alcohol use disorder or illicit drug use

• Actively being treated Atrial fibrillation/ Flutter with Rapid Ventricular Response

• Moderate to severe valve disorders

• Patient with shortwave/microwave therapy equipment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Richmond VA Medical Center	Richmond	Virginia	United States	23249

Sponsors and Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center
• Virginia Commonwealth University

Investigators

• Principal Investigator: Jose Huizar, M.D., Hunter Holmes McGuire Veterans Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Premature ventricular contractions activate vagal afferents and alter autonomic tone: implications for premature ventricular contraction-induced cardiomyopathy
• Relationship between burden of premature ventricular complexes and left ventricular function
• Clinical and translational insights on premature ventricular contractions and PVC-induced cardiomyopathy
• Evaluation and management of premature ventricular complexes
• Stellate ganglion blockade and bilateral cardiac sympathetic denervation in patients with life-threatening ventricular arrhythmias
• Cardiac Sympathetic Denervation for Refractory Ventricular Arrhythmias
• TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial
• Heart rate variability biofeedback based on slow-paced breathing with immersive virtual reality nature scenery.
• Non-invasive low-level tragus stimulation in cardiovascular diseases
• Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice

Publications

None provided.

• Responsible Party: Jose Huizar, Associate Chief of Staff for Research and Development at VAMC, Professor of Medicine at VCU, Director, Arrhythmia and Device Clinic at VAMC and Affiliate Professor of Physiology and Biophysics VCU, Hunter Holmes Mcguire Veteran Affairs Medical Center
• ClinicalTrials.gov Identifier: NCT06110364
• Other Study ID Numbers: 1724039
• First Posted: Oct 31, 2023
• Last Update Posted: Oct 31, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Jose Huizar, Associate Chief of Staff for Research and Development at VAMC, Professor of Medicine at VCU, Director, Arrhythmia and Device Clinic at VAMC and Affiliate Professor of Physiology and Biophysics VCU, Hunter Holmes Mcguire Veteran Affairs Medical Center: HRV-BF- Heart rate variability biofeedback, LLTS- Low-level tragus stimulation, NIVNS Non-invasive vagal nerve stimulation
• Additional relevant MeSH terms: Premature Birth; Ventricular Premature Complexes

Study Results

No Results Posted as of Oct 31, 2023