NCT01829607已完成2 期
Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection Fraction
Attikon Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Exercise capacity
研究概览
简要总结
The purpose of this study is to evaluate the effects of functional electrical stimulation of peripheral muscles on clinical and emotional status, endothelial function and left ventricular diastolic function in heart failure with preserved left ventricular ejection fraction.
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
- Single (Participant)
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
- •(i) symptoms [New York Heart Association (NYHA) class II or III] and signs typical of heart failure
- •(ii) left ventricular (LV) ejection fraction (LVEF) >50% and LV end-diastolic volume index <97 mL/m2
- •(iii) findings of left atrial (LA) dilatation (LA volume index >40mL/m2), LV hypertrophy and/or LV diastolic dysfunction [ie, mitral E/A ratio <1 or >2, mitral E/e' ratio >15 or 8-15, (A pulmonary - A mitral) duration difference >30 ms etc)
- •(iv) no alterations in medical therapy during the previous 4 weeks
- •(v) no myocardial infarction within 3 months prior to enrollment
排除标准
- •recent (≤4 weeks) heart failure decompensation
- •acute coronary syndrome
- •chronic inflammatory diseases and malignancies
结局指标
主要结局
Exercise capacity
时间窗: Six weeks
Quality of life
时间窗: Six weeks
Emotional status
时间窗: Six weeks
次要结局
- Left ventricular diastolic function(Six weeks)
- Endothelial function(Six weeks)
研究者
John Parissis
Assistant Professor of Cardiology
Attikon Hospital
研究点 (1)
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