Peripheral Venous Pressure-Guided Decongestive Therapy in Heart Failure 2
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 16
- 主要终点
- Primary end point: Major adverse events (Mortality and rehospitalization)
研究概览
简要总结
The investigators hypothesize that a simple assessment of peripheral venous pressure (PVP) will better predict the diuretic need and long-term outcomes (all cause mortality, all cause rehospitalization, emergency department visits) compared to standard evaluation.
详细描述
I. BACKGROUND AND SIGNIFICANCE
Precise assessment of volume status is essential in diagnosis and management of diuretic therapy in patients hospitalized for heart failure (HF). Unfortunately, no clear guidelines are present for in-hospital management of congestion. Consequently, nearly half of the patients hospitalized for congestive HF are discharged with persistent congestion. This contributes to high rates of readmission and mortality.
Recently, it has been shown that a simple assessment of peripheral venous pressure (PVP) demonstrates a high correlation with central venous pressure (CVP), indicating that PVP may be useful in the standard bedside clinical assessment of volume status in HF patients to help guiding decongestive therapy.
II. THE HYPOTHESIS
The main hypothesis is as follows: A simple assessment of peripheral venous pressure (PVP) will better guide the diuretic need and long-term outcomes (all-cause mortality, all cause re-hospitalization, emergency department visits) compared to standard evaluation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PVP-Guided
Peripheral venous pressure guided diuretic therapy arm
干预措施: Diuretic therapy (Drug)
Control
Standard dıuretic therapy arm
干预措施: Diuretic therapy (Drug)
结局指标
主要结局
Primary end point: Major adverse events (Mortality and rehospitalization)
时间窗: One year
The difference in the combined rate of all-cause mortality, all-cause hospitalization and all-cause emergency department visits
次要结局
- Secondary combined end point:Major cardiac adverse events (Cardiac mortality and hospitalization)(One year)