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

NCT06950320 | Completed

• 2 other identifiers: EK-No: 2033/20122033/2012
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Keywords

auricular vagal stimulation; chronic heart failure; 6-minute walking test

Outcome Measures

Primary Outcomes (1)

• 6-minutes walking distance test

  patients were asked to walk at comfortable speed for 6min in one of our hospital corridors (30m long), distance was assessed by a physician

  before treatment randomization, study day 21, 35 days after randomization

Secondary Outcomes (10)

• SF 36, quality of life

  before treatment randomization, 35 days after treatment randomization

• adverse events

  before treatment randomization, study day 21, 35 days after randomization

• blood concentration of TNF alpha

  before treatment randomization, 35 days after treatment randomization

• blood concentration of Interleucin 6 (IL6)

  before treatment randomization, 35 days after treatment randomization

• blood concentration of C-reactive protein (CRP)

  before treatment randomization, 35 days after treatment randomization

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Device: Placebo

treatment group

ACTIVE COMPARATOR

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.

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

Interventions

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.

treatment group

Placebo DEVICE

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

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic heart failure
• NYHA Classification II-III
• Stable medication since at least 1 months
• LVEF \<40%
• Patients must be able to understand study conditions

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (18)

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  PMID: 8938579 BACKGROUND

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  PMID: 16129801 BACKGROUND

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  PMID: 20117364 BACKGROUND

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  PMID: 12456484 BACKGROUND

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  PMID: 21303780 BACKGROUND

• Gullestad L, Ueland T, Vinge LE, Finsen A, Yndestad A, Aukrust P. Inflammatory cytokines in heart failure: mediators and markers. Cardiology. 2012;122(1):23-35. doi: 10.1159/000338166. Epub 2012 Jun 12.

  PMID: 22699305 BACKGROUND

• Pomerantz BJ, Reznikov LL, Harken AH, Dinarello CA. Inhibition of caspase 1 reduces human myocardial ischemic dysfunction via inhibition of IL-18 and IL-1beta. Proc Natl Acad Sci U S A. 2001 Feb 27;98(5):2871-6. doi: 10.1073/pnas.041611398.

  PMID: 11226333 BACKGROUND

• Kapadia SR. Cytokines and heart failure. Cardiol Rev. 1999 Jul-Aug;7(4):196-206. doi: 10.1097/00045415-199907000-00011.

  PMID: 10423671 BACKGROUND

• Damas JK, Gullestad L, Ueland T, Solum NO, Simonsen S, Froland SS, Aukrust P. CXC-chemokines, a new group of cytokines in congestive heart failure--possible role of platelets and monocytes. Cardiovasc Res. 2000 Jan 14;45(2):428-36. doi: 10.1016/s0008-6363(99)00262-x.

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• Aukrust P, Ueland T, Muller F, Andreassen AK, Nordoy I, Aas H, Kjekshus J, Simonsen S, Froland SS, Gullestad L. Elevated circulating levels of C-C chemokines in patients with congestive heart failure. Circulation. 1998 Mar 31;97(12):1136-43. doi: 10.1161/01.cir.97.12.1136.

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• Torre-Amione G, Kapadia S, Benedict C, Oral H, Young JB, Mann DL. Proinflammatory cytokine levels in patients with depressed left ventricular ejection fraction: a report from the Studies of Left Ventricular Dysfunction (SOLVD). J Am Coll Cardiol. 1996 Apr;27(5):1201-6. doi: 10.1016/0735-1097(95)00589-7.

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• Aukrust P, Ueland T, Lien E, Bendtzen K, Muller F, Andreassen AK, Nordoy I, Aass H, Espevik T, Simonsen S, Froland SS, Gullestad L. Cytokine network in congestive heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol. 1999 Feb 1;83(3):376-82. doi: 10.1016/s0002-9149(98)00872-8.

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• Peuker ET, Filler TJ. The nerve supply of the human auricle. Clin Anat. 2002 Jan;15(1):35-7. doi: 10.1002/ca.1089.

  PMID: 11835542 BACKGROUND

Study Officials

• Sabine Sator, MD, Professor

  Medical University of Vienna, Dept. of Pain Therapy

  STUDY DIRECTOR

• Regina Patricia Schukro, MD

  Medical University of Vienna, Dept. of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: April 30, 2025
• Study Start: January 1, 2014
• Primary Completion: January 31, 2016
• Study Completion: January 31, 2016
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)