NCT02662439暂停不适用
Role of the Bioimpedance Analysis in Guiding the Diuretic Therapy in Chronic Heart Failure - A Randomized Controlled Trial
Peter Studinger2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Re-hospitalization rate
研究概览
简要总结
The aim of this study is to investigate whether the objective measurement of fluid overload by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated heart failure would improve the diuretic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with known or newly discovered chronic heart failure admitted to hospital because of the clinical signs of acut cardiac decompensation
排除标准
- •High level of fatigue (the patient cannot stand on a scale)
- •Amputated upper and/or lower limb(s)
- •The BCM analysis is not possible technically (e.g. open wounds on the limbs)
- •Severe obesity (>130 kg)
- •Patients on chronic hemodialysis or peritoneal dialysis
- •Severe fluid volume in the transcellular space
- •Patients with a unipolar pacemaker whose sensitivity threshold is very low
- •Pregnancy, lactation
结局指标
主要结局
Re-hospitalization rate
时间窗: 12 months
次要结局
- All cause mortality(12 months)
研究者
Peter Studinger
Assistant Professor
Semmelweis University
研究点 (2)
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