NCT00449423终止2 期
Metabolic Modulation as Treatment in Acute Heart Failure
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- pulmonary Wedge Pressure
研究概览
简要总结
The primary objective of this study is to evaluate whether metabolic modulation improves hemodynamics and outcome in acute heart failure
详细描述
Acute heart failure is a serious disease that despite modern therapies carries a high mortality. Inotropic drugs improve patient status but yield a higher risk of death. Previous studies have shown that myocardial contractility improves when glucose fermentation is up regulated and decreases when Free Fatty Acids are high. In a placebo-controlled design we wish to shift myocardial substrate metabolism towards increased glucose uptake and utilization and measure hemodynamics and biochemical markers of metabolism and prognosis.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute heart failure
- •NYHA class III - IV.
- •ejection fraction <35
排除标准
- •Age <18 år or >85 år,
- •renal failure
- •recently developed brady- or tachy-arrythmias
- •Serious infection
- •Heart failure due to restrictive or hypertrophic cardiomyopathy or stenotic valvular heart disease
- •Recent Myocardial infarction (<6 Weeks)
- •Pulmonary Wedge pressure >30 mm Hg
- •diabetes mellitus treated with insulin
- •peptic ulcer
- •pregnancy
结局指标
主要结局
pulmonary Wedge Pressure
Ejection fraction
Cardiac index
次要结局
- myocardial glucose- and Free Fatty Acid-extraction
- cardiac output
- Regional left ventricle function
- outcome day 6 and 30
研究者
研究点 (2)
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