Assessment of Residual Congestion in Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 580
- 试验地点
- 3
- 主要终点
- Composite of heart failure readmission and all-cause mortality
研究概览
简要总结
DESIGN:
A prospective, multicenter, observational cohort study including 580 patients admitted for acute decompensated heart failure (ADHF).
Ultrasound assessment of congestion (VExUS and LUS) will be performed serially during admission: within 48 hours of admission, at the time diuretic therapy is switched from intravenous to oral, and on the day of discharge. The discharge assessment will serve as the primary predictor.
Treating physicians will be blinded to all ultrasound findings. Patients will be followed for 90 days by telephone follow-up and chart review for the primary endpoint, with extended chart review at one year for selected secondary endpoints.
AIMS:
To determine whether combined ultrasound assessment of venous (VExUS) and pulmonary congestion (LUS) at discharge predicts heart failure readmission and all-cause mortality in patients hospitalized with ADHF.
HYPOTHESIS:
Abnormal VExUS and/or LUS findings at discharge are associated with a higher risk of heart failure readmission and all-cause mortality after 90 days.
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
- •Adults (≥18 years) admitted with ADHF.
- •Clinical evidence of congestion during admission, indicated by ≥1 of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiologic/ultrasound evidence of pulmonary congestion.
- •Treatment with ≥40 mg i.v. furosemide or equivalent dose loop diuretic during admission.
排除标准
- •Solitary kidney
- •Inability to provide written consent
研究组 & 干预措施
Patients admitted for acute decompensated heart failure
结局指标
主要结局
Composite of heart failure readmission and all-cause mortality
时间窗: 90 days
Time-to-event analysis. Endpoints appointed by a blinded adjudication committee. Abnormal VExUS will be defined according to criteria from our ongoing validation study. Abnormal LUS is defined as ≥3 B-lines in ≥2 scanning zones per hemithorax (8-zone method) or ≥15 total B-lines overall.
次要结局
- Days alive and out of hospital(Within 90 days and one year after discharge)
- Individual components of the primary endpoint(90 days and one year after discharge)
- Association between discharge VExUS and markers of congestion(At discharge)
- Incremental prognostic value of discharge VExUS and LUS beyond standard clinical assessment of congestion for predicting 90-day and one-year heart-failure readmission and all-cause mortality(90 days and 1 year)
- Post-discharge diuretic use(90 days)