Vacular Structure, Function and Sympathetic Activity in Takotsubo Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Resting MSNA
研究概览
简要总结
The primary objective of this prospective, observational study is to compare muscle sympathetic nerve activity at rest and during stress between female patients with Takotsubo syndrome and healthy, matched volunteers.
- Do Takotsubo patients have an increased sympathetic nerve activity compared to controls?
- Do Takotsubo patients have an exaggerated sympathetic nerve activity response to stress?
- Does the sympathetic nerve activity response to stress in Takotsubo change after receiving the beta blocking agent metoprolol?
Participants will be examined with muscle sympathetic nerve activity recording in the peroneal nerve at rest and during cold pressor test. After intravenous injection with beta blocking agent (metoprolol) or placebo (saline) in a 1:1 randomized fashion, muscle sympathetic nerve recording at rest and during stress will be repeated.
详细描述
Female Takotsubo patients included in the SAFT (sympathetic and vascular function in Takotsubo syndrome) study will be invited to undergo microneurography recording of muscle sympathetic nerve activity (MSNA) at rest and during stress one week to two month after study inclusion. Responses to stress with and without the commonly used betablocking agent metoprolol will be compares.
Microneurography will be performed in the morning after a light caffeine-free breakfast with the subject supine and awake. Any medication with a beta blocking agent will be discontinued 24 hours prior to examination. MSNA will be recorded by inserting a tungsten electrode into the sympathetic nerve fibres of the peroneal nerve, with simultaneous blood pressure and heart rate monitoring.
MSNA recording will then continue during stress induced by placing one of the subjects hand in ice-cold water for 90 seconds (cold pressor test).
After intravenous injection with beta blocking agent (metoprolol) or placebo (saline) in a 1:1 randomized fashion, MSNA recording at rest and during stress will be repeated.
Age- and gender-matched healthy volunteers will be recruited as controls and examined similarly with microneurography at rest and during stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Intervention single blinded to participant. Intervention blinded to person analyzing the MSNA.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For patients:
- •Diagnosis of Takotsubo cardiomyopathy
- •For Controls:
- •Matching age with Takotsubo patients
- •Signed informed consent
排除标准
- •Coronary anathomy precluding intracoronary investigations
- •Severe obstructive pulmonary disease
- •Kidney failure with estimated glomerular filtration rate < 30 ml/min/m2
- •Active malignancy
- •Pericarditis
研究组 & 干预措施
Takotsubo Control
Patients with Takotsubo receiving betablockade
干预措施: Metoprolol Injection (Drug)
Takotsubo Intervention
Patients with Takotsubo receiving placebo
干预措施: Saline (Drug)
结局指标
主要结局
Resting MSNA
时间窗: During 5 minutes rest
Muscle sympathetic nerve activity during rest
MSNA increase during CPT
时间窗: During the last 60 seconds of the CPT
Muscle sympathetic nerve activity increase during cold pressor test
次要结局
- MSNA increase during CPT after intervention(During the last 60 seconds of the CPT)
- Hemodynamic changes during CPT(During the last 60 seconds of the CPT)