跳至主要内容
临床试验/NCT01000350
NCT01000350进行中(未招募)不适用

Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Difference in VO2max between saline day and placebo day

研究概览

简要总结

The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet diagnostic criteria of Postural Tachycardia Syndrome (POTS) 28
  • Age between 18-65 years
  • Male and female are eligible (although the majority of POTS patients are female).
  • Able and willing to provide informed consent

排除标准

  • Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications)
  • Pregnancy
  • Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
  • Patients who are bedridden or chair-ridden

研究组 & 干预措施

Exercise Post Saline

Experimental

Saline infusion 1L hours before exercise test

干预措施: Saline (Drug)

Placebo

Placebo Comparator

Placebo given prior to exercise test

干预措施: Placebo (Other)

结局指标

主要结局

Difference in VO2max between saline day and placebo day

时间窗: Within 2 week

VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.

次要结局

  • Exercise capacity/Maximal Load (Watts) during peak VO2(Less than 2 weeks)
  • Cardiac output between exercise tests (inert gas rebreathing technique)(2-10 Days between exercise tests)

研究者

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

Satish R. Raj

Adjunct Associate Professor of Medicine

Vanderbilt University Medical Center

研究点 (1)

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