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Completed

NCT Number: NCT06950320

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

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.

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Key information

Conditions

Chronic Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance

Device

P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance weighing 5 grams, designed as a disposable product for a single use. P-STIM is placed behind the patient's ear and connected to stimulation needles (usually 3 needles) on the auricle. For the study, only one stimulation needle was needed. P-STIMTM offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings. The built-in microchip creates periods of stimulation and rest, each lasting approximately 3 hours. Stimulation was performed with a frequency of 1Hz for 40min followed by a break of 20 min.

PLACEBO

Device

The placebo device is a look-a-like, that stimulates only for 1h hour and then stops.

Primary outcomes

  1. 6-minutes walking distance test

    Time frame: 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 outcomes

  1. SF 36, quality of life

    Time frame: 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.

  2. adverse events

    Time frame: 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.

  3. blood concentration of TNF alpha

    Time frame: 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

  4. blood concentration of Interleucin 6 (IL6)

    Time frame: before treatment randomization, 35 days after treatment randomization

    blood samples will be collected, measurement will be in nanogram/litre

  5. blood concentration of C-reactive protein (CRP)

    Time frame: before treatment randomization, 35 days after treatment randomization

    blood samples will be collected, measurement will be in milligram/decilitre

  6. blood concentration of NT-proBNP

    Time frame: before treatment randomization, 35 days after treatment randomization

    blood samples will be collected, measurement will be in picogram/mililitre

  7. left ventricular ejection fraction

    Time frame: 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

  8. NYHA

    Time frame: 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.

  9. blood pressure

    Time frame: 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

  10. ST-elevation

    Time frame: before treatment randomization, 35 days after treatment randomization

    will be detected via electrocardiogram which was performed by a cardiologist

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: COETAV

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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