NCT01837771Unknown不适用
Uni- or Biventricular Pacing and Diaphragmatic Stimulation for Severe Heart Failure (Epiphrenic III Pilot Trial)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction
研究概览
简要总结
The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by interventionally placed electrodes may improve heart function, symptoms and functional capacity in patients with severe heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic heart failure (NYHA functional classes II, III or IV)
- •Reduced left ventricular ejection fraction (LVEF) <35%
- •Guideline-recommended drug therapy
排除标准
- •Patient refuses study participation
- •Life expectancy presumably <1 year
- •Pregnancy
结局指标
主要结局
Left ventricular ejection fraction
时间窗: Four weeks
NYHA functional class
时间窗: Four weeks
次要结局
- Brain natriuretic peptide (BNP)(Four weeks)
- 6-minutes walking test(Four weeks)
研究者
Prof. Paul Erne
Head of Department of Cardiology
Luzerner Kantonsspital
研究点 (2)
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