Randomized Comparison Between Nt-proBNP or Clinical Guided Discharges in Patients Hospitalized With Acute Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Days of hospitalization
研究概览
简要总结
Our objective is to compare a policy of hospital discharge guided by NT-proBNP levels versus discharge guided by conventional clinical criteria, in patients admitted with acute heart failure. The hypothesis is that the Nt-proBNP guided discharge will shorten hospital stay without worsening the outcome
详细描述
Nt-proBNP levels as well as their response to pharmacological treatment are predictive of prognosis in patients with heart failure. The purpose of the present project is to investigate, in patients hospitalized with acute heart failure, whether a discharge decision guided by Nt-proBNP response shortens hospital stay and improves prognosis The included patients will be randomly assigned to one of these two strategies: hospital discharge according to clinical conventional criteria or discharge guided by Nt-proBNP. All patients will be treated following clinical guidelines. In the guided Nt-proBNP strategy, patients will be discharged the third day if NT-proBNP levels drops >30% compared to admission values. If such a reduction is not achieved, then the pharmacological treatment will be increased and NT-proBNP will be measured the following days until reaching the 30% reduction. In the conventional strategy, patients will be discharged at criterion of the attending cardiologist according to clinical assessment without Nt-proBNP. The main outcome will be the number of days of hospitalization at the index episode, and the secondary outcome will be death or readmission by heart failure at one and 6 months. Our hypothesis is that the Nt-proBNP guided discharge will allow to precisely evaluate the response to treatment and to determine the best time for hospital discharge. This will reduce hospital stay and death or readmission rate after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •clinical signs and symptoms of acute heart failure, according to the criteria of the European guidelines
- •NT-proBNP levels > 1000 pg/ml at the time of admission
- •age over 18 years old
- •signed informed consent
排除标准
- •GFR less than 30 ml/minute/m2,
- •life expectancy as determined by concomitant diseases under one year,
- •acute coronary syndrome within 10 days prior,
- •valvular heart disease with surgical approach,
- •infection or process active malignancy,
- •chronic respiratory failure with pulmonary disease.
结局指标
主要结局
Days of hospitalization
时间窗: At the index episode (at discharge)
次要结局
- Death or readmission by heart failure(6 months)
研究者
Juan Sanchis
Full Professor of Medicina
University of Valencia