Assessment of Residual Congestion in Acute Decompensated Heart Failure

NCT07682298 | Recruiting

• 1 other identifier: 1-10-72-199-25
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Acute Heart Failure (AHF); Decompensated Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Composite of heart failure readmission and all-cause mortality

  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

Secondary Outcomes (5)

• 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

Study Arms (1)

Patients admitted for acute decompensated heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Zealand University Hospital: collaborator
• Amager Hospital: collaborator

Study Sites (3)

Aarhus University Hospital - Department of Cardiology

Aarhus, 8200, Denmark

RECRUITING

Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology

Copenhagen, 2650, Denmark

NOT YET RECRUITING

Zealand University Hospital - Department of Cardiology

Roskilde, 400, Denmark

NOT YET RECRUITING

Central Study Contacts

Kristoffer Berg-Hansen, MD, PhD

CONTACT

+4560540700; krisbe@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (3)