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Assessment of Residual Congestion in Acute Decompensated Heart Failure (VExUS-AHF)

2026年7月2日 更新者：Aarhus University Hospital

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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

580

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Kristoffer Berg-Hansen, MD, PhD
  • 电话号码：+4560540700
  • 邮箱：krisbe@rm.dk

学习地点

  • 丹麦
      • Aarhus、丹麦、8200
        • 招聘中
        • Aarhus University Hospital - Department of Cardiology
        • 接触：
          • Kristoffer Berg-Hansen, MD, PhD
          • 电话号码：+456054070
          • 邮箱：krisbe@rm.dk
      • Copenhagen、丹麦、2650
        • 尚未招聘
        • Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology
        • 接触：
      • Roskilde、丹麦、400
        • 尚未招聘
        • Zealand University Hospital - Department of Cardiology
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Inclusion criteria Age ≥18 years admitted with ADHF, treated with intravenous loop diuretics (≥40 mg furosemide or an equivalent dose of another loop diuretic) during admission, and able to provide written consent will be eligible for inclusion. 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.

Exclusion criteria Pregnancy, moribund, solitary kidney, or inability to provide written consent

描述

Inclusion Criteria:

  1. Adults (≥18 years) admitted with ADHF.
  2. 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.
  3. Treatment with ≥40 mg i.v. furosemide or equivalent dose loop diuretic during admission.

Exclusion Criteria:

  1. Pregnancy
  2. Moribund
  3. Solitary kidney
  4. Inability to provide written consent

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Patients admitted for acute decompensated heart failure

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Composite of heart failure readmission and all-cause mortality
大体时间：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.
90 days

次要结果测量

结果测量
措施说明
大体时间
Days alive and out of hospital
大体时间：Within 90 days and one year after discharge
Days alive and out of any hospital within 90 days and 1 year, indexed to discharge; death counts as 0 days. Computed over the complete fixed window using chart-based ascertainment of vital status and admissions. Patients censored early for reasons other than death (e.g. withdrawal) are handled by censoring or exclusion (not scored 0, since 0 denotes death). Analyzed with rank-based methods given the zero-spike and skew.
Within 90 days and one year after discharge
Individual components of the primary endpoint
大体时间：90 days and one year after discharge
90 days and one year after discharge
Association between discharge VExUS and markers of congestion
大体时间：At discharge
Markers of congestion: Objective markers (jugular venous pressure, peripheral edema, pulmonary rales, and weight change), NT-proBNP, renal function, and echocardiographic measures of cardiac function.
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
大体时间：90 days and 1 year
90 days and 1 year
Post-discharge diuretic use
大体时间：90 days
Defined as the change in loop diuretic dose (furosemide-equivalent) from discharge to 30- and 90-day follow-up, and occurrence of diuretic intensification (dose increase or addition of thiazide-type diuretic) within 90 day
90 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Aarhus University Hospital

合作者

Zealand University Hospital
Amager Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月15日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年11月1日

研究注册日期

首次提交

2026年6月26日

首先提交符合 QC 标准的

2026年6月26日

首次发布 (实际的)

2026年7月2日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年7月2日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1-10-72-199-25

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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