Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change in Orthostatic BP Drop
研究概览
简要总结
Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension.
详细描述
In patients with neurogenic orthostatic hypotension, the appropriate treatment was identified by comparing the treatment effects and side effects for each treatment drug. In addition, by confirming the effect of orthostatic hypotension on lowering the quality of life, it is expected that the improvement of the quality of life will help.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age >=18 patients who complained of dizziness
- •Orthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or diastolic blood pressure drop >=10
排除标准
- •Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month
- •Heart failure or Chronic renal failure
- •Patients who cannot or do not want to write questionaires.
- •Poor drug compliance
研究组 & 干预措施
Midodrine
Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
干预措施: Midodrine (Drug)
Pyridostigmine
Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
干预措施: Pyridostigmine Bromide (Drug)
Midodrine + Pyridostigmine
Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
干预措施: Midodrine + pyridostigmine (Drug)
结局指标
主要结局
Change in Orthostatic BP Drop
时间窗: after 3-month medical treatment
Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.
次要结局
- Changes in Health-related Quality of Life(changes at 3 months after treatment)
- Change of the Depression Score (Beck Depression Inventory-II )(after 3-month medical treatment.)
- Short-form 36 Version 2(changes at 3 months after treatment)
- Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).(after 3-month medical treatment.)
研究者
Kon Chu
Professor
Seoul National University Hospital