Comparison of Effect of Propranolol, Bisoprolol, Pyridosgitmine in Postural Orthostatic Tachycardia Syndrome (POTS) and Prognosis After Medical Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The change of the subjective symptom survey result after 3-month medical treatment.
研究概览
简要总结
The purpose of the study is to investigate effect of medical treatment and prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)
详细描述
Many patients who complained of dizziness are eventually diagnosed as POTS. However, the investigation of an appropriate medical treatment of POTS has not been enough yet. Also, the prognosis of the disease after treatment is not well known. It is known that propranolol attenuate the tachycardia and improve symptom burden in patients with POTS. However, the effect of other β-Blocker, bisoprolol compared with propranolol is not known well. In addition, acetylcholinesterase inhibition with pyridostigmine was a effective method of acutely decreasing the tachycardia in patients with POTS. However, difference among three medical treatments effect is not known and long-term studies are not done yet. Therefore, in this study investigator investigate effect of medical treatment (propranolol only, bisoprolol only, propranolol+pyridostigmine, bisoprolol+pyridostigmine) and prognosis of Postural Orthostatic Tachycardia Syndrome.
Longer-term studies are needed to assess this promising therapy.
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
- None
入排标准
- 年龄范围
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 15<=
- •developed symptoms of orthostatic intolerance accompanied by a HR rise ≥30 min-1 within the first 10 minutes of standing, HR rise ≥ 120 in the absence of orthostatic hypotension (a fall in blood pressure [BP] >20/10 mm Hg).
排除标准
- •poor drug compliance
- •patients who cannot or do not want to write questionaires.
- •patients who do not want draw blood
研究组 & 干预措施
Propranolol
Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable
干预措施: Propranolol (Drug)
Bisoprolol
Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable
干预措施: Bisoprolol (Drug)
Propranolol+pyridostigmine
Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.
干预措施: Propranolol+pyridostigmine (Drug)
Bisoprolol+pyridostgmine
start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable
干预措施: Bisoprolol+pyridostgmine (Drug)
结局指标
主要结局
The change of the subjective symptom survey result after 3-month medical treatment.
时间窗: 3 month after medical treatment
次要结局
- The change of the subjective symptom after 6-month medical treatment.(6 month)
- Change of quality of life score after treatment(6 month)
- Normalization of orthostatic BP-HR test after 6-month medical treatment.(6 month)
- Change of depression score after treatment(6 month)
研究者
Kon Chu
MD, PhD, professor
Seoul National University Hospital