NCT00171106已完成4 期
A Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Determine the Effects of Valsartan on Exercise Time in Subjects With Symptomatic Diastolic Heart Failure
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in baseline exercise test after 15-42 days and 14 weeks
研究概览
简要总结
This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure
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
- Double
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic diastolic heart failure
- •Breathlessness with physical exertion
排除标准
- •Uncontrolled hypertension
- •Asthma, COPD, or abnormal lung function
- •History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
- •Liver, kidney, or pancreas disease
- •Allergy to valsartan
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Change in baseline exercise test after 15-42 days and 14 weeks
次要结局
- Borg score of breathlessness
- Quality of life assessment at baseline and after 14 weeks
- Exercise test blood pressure
- 6-minute walk test at baseline and after 14 weeks
- Oxygen consumption during the exercise test
研究者
研究点 (2)
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