NCT00170924已完成4 期
A Multi-center, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of the Angiotensin II Antagonist Valsartan on Diastolic Function in Patients With Hypertension and Diastolic Dysfunction
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
- 317
- 试验地点
- 2
- 主要终点
- Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram
研究概览
简要总结
Patients who have had high blood pressure for a long time may have diastolic dysfunction. Diastolic Dysfunction is when your heart has difficulty filling and emptying, and relaxing adequately.
This study is to find out if Valsartan) will improve the ability of the heart to fill, empty, and relax appropriately when given alone or with other medicines to treat high blood pressure.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis/History of high blood pressure
- •Male or Female age 45 years or older
排除标准
- •History of stroke, transient ischemic attack or heart attack within the last 6 months
- •A hospital admission for congestive heart failure within the last year
- •Use of certain high blood pressure medications such as ACE inhibitors, Angiotensin Receptor Blockers or aldosterone antagonists or other agents that may work in the same pathway (RAAS) as valsartan within the past 3 months.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline in diastolic heart function at 38 weeks, measured by echocardiogram
次要结局
- Change from baseline in the wall thickness of left heart ventricle after 38 weeks
- Change from baseline in the size (mass) left heart ventricle after 38 weeks
- Change from baseline in heart function after 38 weeks
- Change from baseline in circulating marker of ventricular function after 38 weeks
- Change from baseline in circulating marker of inflammation
研究者
研究点 (2)
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