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Recruiting Observational

Assessment of Residual Congestion in Acute Decompensated Heart Failure

NCT07682298 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2026-02-15
Last updated
2026-07-07

Condition(s) studied

Acute Heart Failure (AHF)Decompensated Chronic Heart Failure

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite of heart failure readmission and all-cause mortality — 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.

Trial sites (3)

FacilityCityRegionStatus
Aarhus University Hospital - Department of Cardiology Aarhus Denmark Recruiting
Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology Copenhagen Denmark Not Yet Recruiting
Zealand University Hospital - Department of Cardiology Roskilde Denmark Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07682298 on ClinicalTrials.gov ↗ ← All trials in Denmark