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

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.

PRIMARY ENDPOINT:

The primary endpoint is a composite of heart failure readmission and all-cause mortality (time-to-event analysis) after a 90-day period (chart review). 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.

The primary analysis will evaluate the association between discharge VExUS and LUS findings and the risk of 90-day heart failure readmission and all-cause mortality using Cox proportional hazards regression. Models will be adjusted for age, sex, and comorbidities.

SECONDARY ENDPOINTS:

1. DAOH within 90 days and one year after discharge
2. All-cause mortality within 90 days and one year after discharge
3. Rehospitalization for ADHF within 90 days and one year after discharge
4. Association between discharge VExUS and markers of congestion, including objective markers (jugular venous pressure, peripheral edema, pulmonary rales, and weight change), NT-proBNP, renal function, and echocardiographic measures of cardiac function.
5. Incremental prognostic value of discharge VExUS and LUS beyond standard clinical assessment of congestion (jugular venous pressure, peripheral edema, pulmonary rales, and weight change) for predicting 90-day and one-year heart-failure readmission and all-cause mortality.
6. Post-discharge diuretic use, 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 days.

Secondary analyses will employ Cox models for time-to-event outcomes (readmission, mortality, diuretic intensification) and linear regression for continuous outcomes (DAOH, change in diuretic dose). The relationship between discharge VExUS/LUS and post-discharge diuretic use will be evaluated both continuously (dose change) and categorically (intensification vs. no intensification). Incremental prognostic value beyond clinical and biochemical markers (e.g., NT-proBNP) will be assessed using nested model comparisons (likelihood ratio tests, AIC, C-index, NRI, IDI).

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

Study Overview

• Status: Recruiting
• Conditions: Acute Heart Failure (AHF); Decompensated Chronic Heart Failure

• Study Type: Observational
• Enrollment (Estimated): 580

Contacts and Locations

• Study Contact: Name: Kristoffer Berg-Hansen, MD, PhD; Phone Number: +4560540700; Email: krisbe@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital - Department of Cardiology
    • Contact: Kristoffer Berg-Hansen, MD, PhD; Phone Number: +456054070; Email: krisbe@rm.dk
  • Copenhagen, Denmark, 2650
    • Not yet recruiting
    • Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology
    • Contact: Johannes Grand, MD, PhD; Email: johannes.grand@regionh.dk
  • Roskilde, Denmark, 400
    • Not yet recruiting
    • Zealand University Hospital - Department of Cardiology
    • Contact: Martin Frydland, MD, PhD; Email: mafry@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients admitted for acute decompensated heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days alive and out of hospital	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		90 days and one year after discharge
Association between discharge VExUS and markers of congestion	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		90 days and 1 year
Post-discharge diuretic use	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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Zealand University Hospital; Amager Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1-10-72-199-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No