NCT00493480已完成3 期
Danish Carvedilol Study in Portal Hypertension. Carvedilol in the Prevention of Bleeding in Portal Hypertension and Esophageal Varices
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment
研究概览
简要总结
Patients with large esophageal varices who have not yet experienced bleeding, are normally treated with propranolol, a beta blocking agent that reduces the portal pressure and thereby diminish the risk of bleeding. 20-40% of the patients do not respond to this treatment or have to discontinue the treatment because of side effects. The aim of this study is to evaluate if carvedilol (a combined alfa -beta blocker) has better efficacy and safety than propranolol in lowering the portal pressure in patients with cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis
- •HVPG > 12 mmHg
排除标准
- •Respiratory disease that contradict endoscopy
- •Hepatic encephalopathy
- •Hepatorenal syndrome
- •COPD or Asthma
- •Treatment with vasoactive drugs within 1 week of inclusion
- •Heart disease that contradict treatment with beta-blocking agents
- •Pregnancy
研究组 & 干预措施
carvedilol
Active Comparator
干预措施: carvedilol (Drug)
propranolol
Active Comparator
Cirrhotic patients treated with propranolol
干预措施: propranolol (Drug)
结局指标
主要结局
If carvedilol is better than propranolol in lowering portal pressure after 3 months of treatment
时间窗: 3 months
次要结局
- If the effect of a single dose of propranolol can predict the long term effect of propranolol or carvedilol(3 months)
研究者
研究点 (1)
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