Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Total Natriuresis After 24 Hours
研究概览
简要总结
Administration of loop diuretics to achieve decongestion is the current cornerstone of therapy for acute heart failure. Unfortunately, there is a lack of evidence of how to guide diuretic treatment. Recently, urinary sodium, as a response measure of diuretic response, has been proposed as a target for therapy. The hypothesis of this study is that natriuresis guided therapy in patients with acute heart failure will improve diuretic response, decongestion, and reduce length of hospital stay, as well as heart failure rehospitalisations.
详细描述
Objective: To assess the effect of natriuresis guided therapy in acute heart failure to improve diuretic response, decongestion, and clinical outcomes
Study design: Randomised, controlled, open label study
Study population: 310 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics.
Intervention: natriuresis guided treatment versus standard of care
Main study parameters/endpoints:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age
- •Primary diagnosis of acute /decompensated heart failure as assessed by treating physician
- •a. Acute Heart failure can be de novo or exacerbation of known heart failure and diagnosis is based on criteria in the ESC HF guidelines
- •Requirement of intravenous diuretic use
排除标准
- •Dyspnoea primarily due to non-cardiac causes
- •Patients with severe renal impairment receiving dialysis or requiring ultrafiltration
- •Inability to follow instructions
- •Any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study
结局指标
主要结局
Total Natriuresis After 24 Hours
时间窗: 24 hours
The first component of the co-primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 hours after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).
First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days
时间窗: 180 days
次要结局
- 48-hours Natriuresis(48 hours)
- 72-hours Natriuresis(72 hours)
- Length of Hospital Stay(Variable)
- Percentage Change in NT-proBNP at 48 Hours(48 hours)
- Percentage Change in NT-proBNP at 72 Hours(72 hours)
研究者
Jozine ter Maaten
Principle investigator
University Medical Center Groningen