Clinical Outcome of Electrical Transcutaneous Auricular Vagal Stimulation in Patients With Stable Symptomatic Chronic Heart Failure

Not Applicable

Completed

• Conditions: Chronic Heart Failure

• Registration Number: NCT06950320
• Lead Sponsor: Medical University of Vienna

Brief Summary

This study aims to investigate whether electrical vagus nerve stimulation in the auricle has an impact on the clinical presentation of heart failure. The device used, P-STIM, is already successfully applied in pain therapy and angiology (peripheral arterial disease, PAD) and will also be tested against a placebo in this study.

In preliminary studies, acupuncture was shown to improve the 6-minute walking distance in heart failure patients (Kristen et al., 2010). The investigators assume that acupuncture and P-STIM have similar effects, and this study also aims to improve the 6-minute walking distance as its primary endpoint. Additional endpoints include LVEF (left ventricular ejection fraction), NYHA classification, inflammatory markers (e.g., CRP, pro-BNP), and patients' quality of life.

Study Design:

Patients will be randomly assigned to either the placebo or the verum group. They will receive treatment for five weeks (with the device being replaced weekly) and undergo a follow-up examination after four weeks.

At the beginning and during follow-up, Left ventricular ejection fraction (measured by cardiac ultrasound), inflammatory markers in the blood, NYHA classification, and quality of life (assessed by questionnaire) will be recorded. The primary endpoint, the 6-minute walking distance, will be measured at baseline, two weeks after the start of treatment, and at the follow-up examination.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-01-31
• Study Completion: 2016-01-31
• Study First Submitted: 2025-02-27
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Chronic heart failure
• NYHA Classification II-III
• Stable medication since at least 1 months
• LVEF <40%
• Patients must be able to understand study conditions
• No exclusion criteria
• Signed informed consent 6.1.3 Exclusion criteria
• Any electrical auricular vagal stimulation treatment within 6 months prior to base line visit
• Participation in another clinical trial within 3 months prior to base line visit
• Ventricular tachyarrhythmia within 1 month prior to base line visit
• Psoriasis vulgaris
• Hemophilia
• Cardiac pace makers

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6-minutes walking distance test	before treatment randomization, study day 21, 35 days after randomization	patients were asked to walk at comfortable speed for 6min in one of our hospital corridors (30m long), distance was assessed by a physician

Secondary Outcome Measures

Name	Time	Method
ST-elevation	before treatment randomization, 35 days after treatment randomization	will be detected via electrocardiogram which was performed by a cardiologist
SF 36, quality of life	before treatment randomization, 35 days after treatment randomization	The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.; The possible score ranges from 0 to 100 points whereby 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions.
adverse events	before treatment randomization, study day 21, 35 days after randomization	An AE/ADE is any adverse change from the subject's baseline condition, i.e. any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease which is considered to be clinically relevant be the physician that occurs during the course of the, whether or not considered related to the medical device.; Adverse event /ADE include: * Exacerbation of a pre-existing disease.; * Increase in frequency or intensity of a pre-existing episodic disease or medical condition.; * Disease or medical condition detected or diagnosed after treatment with the medical device even though it may have been present prior to the start of the clinical investigation.; * Continuous persistent disease or symptoms present at baseline that worsen following the start of the clinical investigation.; * Lack of efficacy in the acute treatment of a life-threatening disease.; * Events considered by the investigator to be related to clinical investigation-mandated procedures.
blood concentration of TNF alpha	before treatment randomization, 35 days after treatment randomization	blood samples will be collected before treatment randomization and at end of study, measurement will be in picogram/millilitre
blood concentration of Interleucin 6 (IL6)	before treatment randomization, 35 days after treatment randomization	blood samples will be collected, measurement will be in nanogram/litre
blood concentration of C-reactive protein (CRP)	before treatment randomization, 35 days after treatment randomization	blood samples will be collected, measurement will be in milligram/decilitre
blood concentration of NT-proBNP	before treatment randomization, 35 days after treatment randomization	blood samples will be collected, measurement will be in picogram/mililitre
left ventricular ejection fraction	before treatment randomization, 35 days after treatment randomization	left ventricular ejection fraction will be assessed by an experienced cardiologist via echocardiography and will be expressed as percentage of a normal value
NYHA	before treatment randomization, 35 days after treatment randomization	New York Heart Association Classification, will be expressed in 4 stages Class I (Mild) No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild) Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III (Moderate) Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe) Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
blood pressure	before treatment randomization, 35 days after treatment randomization	blood pressure will be assessed non-invasively by a cardiologist and will be expressed as millimeter mercury

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria