Role of the Bioimpedance Analysis in Guiding the Diuretic Therapy in Chronic Heart Failure - A Randomized Controlled Trial
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
- 1
- 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
研究组 & 干预措施
BCM group
The patients are measured by Body Composition Monitor (BCM) and both the patient and the physician know the results and adjust the diuretic therapy accordingly.
干预措施: Body Composition Monitor (BCM) (Device)
Control group
The patients are measured by Body Composition Monitor (BCM) but neither the patient nor the physician know the results, the physician adjusts the diuretic therapy as usual, according to the protocols.
干预措施: Body Composition Monitor (BCM) (Device)
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