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NCT Number: NCT07682298

Assessment of Residual Congestion in Acute Decompensated Heart Failure

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.

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Key information

Conditions

Acute Heart Failure (AHF) Decompensated Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital - Department of Cardiology, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Pregnancy
  • Moribund
  • Solitary kidney
  • Inability to provide written consent

Treatment and study plan

Primary outcomes

  1. Composite of heart failure readmission and all-cause mortality

    Time frame: 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.

Secondary outcomes

  1. Days alive and out of hospital

    Time frame: 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.

  2. Individual components of the primary endpoint

    Time frame: 90 days and one year after discharge

  3. Association between discharge VExUS and markers of congestion

    Time frame: 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.

  4. 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

    Time frame: 90 days and 1 year

  5. Post-discharge diuretic use

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kristoffer Berg-Hansen, MD, PhD

CONTACT

[email protected]

+4560540700

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Amager Hospital
  • Zealand University Hospital

Registry information

Acronym: VExUS-AHF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 2, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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