Multiparametric Assessment of Residual Congestion at Discharge in Patients With Acute Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Worsening heart failure or cardiovascular death
研究概览
简要总结
Treatment of congestion is one of the main goals in patients hospitalized for acute heart failure. Nevertheless, current evidence shows that decongestion is often not achieved and that residual congestion at discharge is strongly associated with poor outcomes. While this association has been demonstrated, previous studies have primarily focused on single parameters of congestion (physical examination, biomarkers, or imaging features). The aim of the study is to assess residual congestion at discharge using a multiparametric approach and to compare the prognostic value of each evaluation strategy. Additionally, the analysis will be supported by artificial intelligence to develop a multiparametric prognostic algorithm that can provide an improved predictive model compared to standard statistical approaches.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years.
- •Patients hospitalized for new onset heart failure or worsening heart failure defined by:
- •Symptoms classified as New York Heart Association class III or IV.
- •Clinical or instrumental signs of volume overload (e.g., dyspnea with evidence of pulmonary congestion on X-rays or lung ultrasound, pitting edema, and jugular venous distension).
- •Elevated NT-proBNP levels within the first 24 hours of admission (cutoff values: 450 ng/L for patients < 50 years; >900 ng/L for patients aged 50-75 years; >1800 ng/L for patients >75 years).
- •Ability to provide informed consent.
排除标准
- •Known diagnosis of septicemia.
- •Glomerular filtration rate < 15 ml/min.
- •Life expectancy < 6 months.
- •Active myocarditis.
- •Heart transplant recipients.
- •Patients with ventricular assist devices.
- •Congenital heart diseases.
- •Moderate-to-severe liver disease (Child-Pugh B-C).
- •Patients that will not be followed up by the Heart Failure Unit.
结局指标
主要结局
Worsening heart failure or cardiovascular death
时间窗: 6 months after hospital discharge
Occurrence of the composite of cardiovascular death and worsening heart failure (defined as unplanned hospitalization or urgent visit resulting in diuretic intravenous therapy)
次要结局
- all-cause death(6 months after hospital discharge)
- time to first heart failure event(6 months after hospital discharge)
- number of heart failure events(6 months after hospital discharge)