Clinical Outcome of Electrical Auricular Vagal Stimulation in Patients With Stable Symptomatic Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- 6-minutes walking distance test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic heart failure
- •NYHA Classification II-III
- •Stable medication since at least 1 months
- •LVEF <40%
- •Patients must be able to understand study conditions
排除标准
- •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
研究组 & 干预措施
Placebo
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.
干预措施: Placebo (Device)
treatment group
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.
干预措施: P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance (Device)
结局指标
主要结局
6-minutes walking distance test
时间窗: 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
次要结局
- ST-elevation(before treatment randomization, 35 days after treatment randomization)
- blood concentration of NT-proBNP(before treatment randomization, 35 days after treatment randomization)
- left ventricular ejection fraction(before treatment randomization, 35 days after treatment randomization)
- 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)
- NYHA(before treatment randomization, 35 days after treatment randomization)
- blood pressure(before treatment randomization, 35 days after treatment randomization)
研究者
Regina Patricia Schukro
Principal Investigator
Medical University of Vienna