Autonomic Modulation in Takotsubo Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- heart rate variability
研究概览
简要总结
This is a minimal risk case-controlled single arm intervention study, including 10 patients with a prior history of takotsubo and 10-age and sex matched healthy controls. Subjects will undergo in laboratory testing to measure autonomic function. They will then undergo a 15-week program of device-guided breathing with remote measures of autonomic function obtained at home. Analysis will determine the reproducibility of home autonomic measures and the provide preliminary data to determine the efficacy of device-guided breathing on autonomic measures and quality of life in patients with takotsubo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed history of takotsubo syndrome
- •Healthy person with no significant past history of cardiovascular or neurological disease such as heart failure or heart attack; people with cardiovascular risk factors such as hypertension will be permitted to participate
排除标准
- •Pacemaker or defibrillator implanted
- •Evidence of autonomic neuropathy, alcohol or drug abuse or exposure to neurotoxins (chemotherapy).
研究组 & 干预措施
Participants in the NYU takotsubo registry
10 patients with a confirmed history of takotsubo syndrome
10 age- and sex-matched healthy controls with no significant history of cardiac or neurological illness
干预措施: Tako Breath (Device)
结局指标
主要结局
heart rate variability
时间窗: 10 Weeks
Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch
次要结局
未报告次要终点