Chronic Heart Failure
Conditions
Keywords
auricular vagal stimulation, chronic heart failure, 6-minute walking test
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.
Interventions
DEVICEP-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance
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.
DEVICEPlacebo
The placebo device is a look-a-like, that stimulates only for 1h hour and then stops.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| ST-elevation | before treatment randomization, 35 days after treatment randomization | will be detected via electrocardiogram which was performed by a cardiologist |
| blood concentration of NT-proBNP | before treatment randomization, 35 days after treatment randomization | blood samples will be collected, measurement will be in picogram/mililitre |
Countries
Austria
Outcome results
None listed