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

Medical University of Vienna

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Device: Placebo; Device: P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT06950320

EK-No: 2033/2012

2033/2012 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients received a placebo device which was a look-a-like, that stimulated only for 1h hour and then stopped. Patients in both groups were told that they will not feel the stimulation after a while, which might contribute to a better blinding between the groups.

Treatment:

Device: Placebo

treatment group

Active Comparator group

Description:

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-STIM 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. After some time, the patient may feel as if the intensity of stimulation is decreasing. A decrease in the perceived intensity of stimulation may however be subjective and have no bearing on the effectiveness of the therapy.

Treatment:

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