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临床试验/NCT03317249
NCT03317249Unknown不适用

Pregnancy Related Inappropriate Sinus Tachycardia Syndrome Study

Cambridge University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年10月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia

研究概览

简要总结

A feasibility study into the exploration of possible mechanisms underlying inappropriate sinus tachycardia (IST) syndrome in pregnancy.

详细描述

This is a non-interventional, physiological study which will explore the feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia, with the aim of providing scope for future research.

Sinus tachycardia (normal heart rhythm but fast heart rate) is common and usually related to an obvious cause (e.g. exercise such a running or cycling) and doesn't cause any untoward symptoms. In rare cases however, sinus tachycardia can occur without an obvious cause (i.e. it is inappropriate to the situation) and can cause distressing symptoms such as palpitations, dizziness and breathlessness at rest or with minimal exertion. This syndrome of inappropriate sinus tachycardia is poorly understood and can be difficult to manage; especially when the affected individual is pregnant. In order to understand the condition better and improve care pathways we aim to measure various features of the cardiovascular system in pregnant women with and without IST.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged 18-45 years of age
  • Able to give written informed consent and willing to participate
  • The participant falls into one of the below categories:
  • i. Pregnant women with IST ii. Pregnant women without IST

排除标准

  • Obesity (BMI > 29.9)
  • Current or recent (within last 3 months) smoker
  • Known medical condition likely to affect HRV (other than IST in relevant groups)
  • Previous history of hypertensive disorders in pregnancy
  • Lack of written informed consent

结局指标

主要结局

Feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia

时间窗: Up to 3 years

Number of women in each group who agree to participate in the study

Assessment of autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia

时间窗: Up to 3 years

Baroreflex sensitivity (BRS) at rest calculated from the change in systolic pressure and change in R-R interval to give change in pressure per change in RR interval, measured in milliseconds (mmHg/ms)

次要结局

  • Assessment of ANS function in pregnant women with and without IST, at rest and during mild exercise(Up to 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Mark Belham

Consultant Cardiologist

Cambridge University Hospitals NHS Foundation Trust

研究点 (1)

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