跳至主要内容
临床试验/NCT00188045
NCT00188045终止4 期

Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients

University Hospital, Angers0 个研究点目标入组 54 人开始时间: 1995年4月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
54
主要终点
assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.

研究概览

简要总结

The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Indication of transjugular hepatic biopsy
  • •alcoholic cirrhosis
  • •presence of oesophageal varices ≤ stade 2

排除标准

  • •renal insufficiency
  • •natremia ≤ 135 mmol/l
  • •vasoactive treatment in the last month before inclusion
  • •hepatocellular carcinoma
  • •positive HIV and HCV patients
  • •paracentesis in the last week before inclusion
  • •digestive bleeding in one last week
  • •oesophageal varices stade 3 or 2 with red signs

结局指标

主要结局

assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.

次要结局

  • Efficacy of spironolactone/propranolol association

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov

相似试验

Hemodynamic Effects of Chronic Administration of... | 临床试验