Noninvasive Neuromodulation to Reserve Diastolic Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Echocardiographic Markers of Diastolic Dysfunction
研究概览
简要总结
This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham or sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to the tragus of the ear, which is innervated by auricular branch of the vagus nerve. Echocardiography will be performed after 30 minutes of LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will be obtained for HRV analysis every 15 minutes of stimulation (total of 4 recordings).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients older than 18 year old
- •Evidence of diastolic dysfunction on echocardiogram within 24 months of study enrollment
排除标准
- •Left ventricular dysfunction (Left ventricular ejection fraction <40%)
- •Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
- •Recent (<6 months) stroke or myocardial infarction
- •Severe heart failure (NYHA class III or IV)
- •Recurrent vaso-vagal syncopal episodes
- •Unilateral or bilateral vagotomy
- •Pregnancy or breast feeding
- •Sick sinus syndrome (without a pacemaker), 2nd or 3rd degree AV block, bifascicular block or prolonged (PR>300ms) 1st degree AV block
结局指标
主要结局
Echocardiographic Markers of Diastolic Dysfunction
时间窗: after 1 hour of stimulation
Global longitudinal strain
次要结局
- Heart Rate Variability Measures(after 1 hour of stimulation)
研究者
Stavros Stavrakis
Assistant Professor
University of Oklahoma