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临床试验/NCT01761825
NCT01761825Unknown2 期

The Effect of "Funny" Channel Blocker Ivabradine on Patients With Postural Tachycardia Syndrome.

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 20 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
20
主要终点
the change in heart rate after the administration of Ivabradine

研究概览

简要总结

The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with POTS by the following criteria:
  • The presence of characteristic orthostatic symptoms of the POTS for at least six months.
  • An increase in the heart rate of at least 30 beats per minute (without concomitant significant decrease in blood pressure of more than 20/10 mmHg) within 10 minutes after assuming a standing position (or during tilt test) on at least 3 separate occasions.
  • No other concomitant diseases that could explain the symptoms of POTS.

排除标准

  • History of systemic illness capable of affecting of affecting autonomic function (eg, diabetes mellitus, SLE).
  • History of cardiovascular disease.
  • History of smoking, drug or alcohol abuse.
  • Pregnancy, and also uncontrolled thyroid or adrenal disorders.
  • Using any drug metabolized by cytochrome P450 3A4 enzyme during the last 72 hours.

研究组 & 干预措施

Ivabradine

Active Comparator

Ivabradine 10 mg once

干预措施: ivabradine (Drug)

结局指标

主要结局

the change in heart rate after the administration of Ivabradine

时间窗: 60 minutes , during the whole trial

the change in blood pressure after the administration of Ivabradine

时间窗: 60 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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