Neuromodulation in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Heart rate variability
研究概览
简要总结
Patients with Group 1 pulmonary hypertension will be enrolled in this study. Investigators will test the hypothesis of low-level tragal stimulation in patients with pulmonary hypertension. The study will be conducted over 4 weeks and patients will undergo low-level tragus stimulation for 1 hour every day for 4 weeks. At baseline the following tests will be conducted-6-minute walk distance, vascular function testing using noninvasive device and blood samples will be collected. Patient will also undergo a limited echocardiography to assess right ventricular function. After 4 weeks of stimulation patients will come back to undergo these tests again. Investigators hypothesized that low-level tragus stimulation (neuromodulation) will lead to improvement in vascular function, 6-minute walk distance and blood based biomarkers in patients with pulmonary hypertension.
详细描述
Investigators propose the following aims:
Aim 1: Quantitatively measure effects of LLTS on exercise capacity and quality of life in Pulmonary hypertension. A 6MWD and QoL (using Pulmonary hypertension questionnaire) will be performed at baseline and follow up (1 months).
Hypothesis 1: Short term LLTS would lead to improvement in exercise capacity and QoL.
Aim 2: Measure effect of neuromodulation on autonomic tone and inflammation. Heart rate variability (frequency and time domains) will be measured at baseline and after 1 months of LLTS. Serum will be used to analyze NT-Pro BNP, circulating inflammatory markers (IL-6,IL-18,TNF-a, IL1ra and CRP).
Hypothesis 2: Short term LLTS would lead to improvement in autonomic tone and inflammation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Both patient's and principal investigator and outcomes assessor will be blinded to the allocation am of the study
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
- •Patients older than 18 years of age, with pulmonary arterial hypertension (Group 1 PH) and WHO functional class II/III
排除标准
- •Exclusion:Patients with Inability to walk, wheelchair-bound, amputations, expected survival less than 3 to 6 months, active malignancy patients who are Spanish-speaking. would be excluded from the study.
结局指标
主要结局
Heart rate variability
时间窗: 4 weeks
Change in the heart rate variability metrics. These are reflective of the autonomic tone and the imbalance. Investigators hypothesized that using low-level tragus stimulation in patients with pulmonary hypertension the heart rate variability will be favorably affected using low-level tragus stimulation compared to sham stimulation. Time domain metrics are usually measured using variation of the standard R-R interval on the EKG in milliseconds.
次要结局
- 6-minute walk distance(4 weeks)