Acute Heart Failure (AHF)VExUS-AHFNCT07682298
Assessment of Residual Congestion in Acute Decompensated Heart Failure
An observational study of Acute Heart Failure (AHF) and Decompensated Chronic Heart Failure, run by Aarhus University Hospital at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Decompensated Chronic Heart Failure
- How many people
- 580 participants
- Where
- 3 sitesDenmark
- Study dates
- 15 Feb 2026to 1 Nov 2028
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Moribund
- Solitary kidney
- Inability to provide written consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus University Hospital - Department of Cardiology
Aarhus, 8200
Kristoffer Berg-Hansen, MD, PhD, +456054070, krisbe@rm.dk
- Not yet recruiting
Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology
Copenhagen, 2650
Johannes Grand, MD, PhD, johannes.grand@regionh.dk
- Not yet recruiting
Zealand University Hospital - Department of Cardiology
Roskilde, 400
Martin Frydland, MD, PhD, mafry@regionsjaelland.dk
About this study
DESIGN:
A prospective, multicenter, observational cohort study including 580 patients admitted for acute decompensated heart failure (ADHF).
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted for acute decompensated heart failure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (5)
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.
Measured: Within 90 days and one year after discharge
Individual components of the primary endpoint
Measured: 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.
Measured: 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
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start15 Feb 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 580 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, Amager Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682298
- Sponsor's protocol ID
- 1-10-72-199-25
- Acronym
- VExUS-AHF
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Residual Congestion in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07682298
- Acronym / sponsor ID
- VExUS-AHF / 1-10-72-199-25
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Zealand University Hospital, Amager Hospital
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted for acute decompensated heart failure | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Pregnancy
- Moribund
- Solitary kidney
- Inability to provide written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Days alive and out of hospital
Time frame: Within 90 days and one year after discharge
Individual components of the primary endpoint
Time frame: 90 days and one year after discharge
Association between discharge VExUS and markers of congestion
Time frame: 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
Time frame: 90 days and 1 year
Post-discharge diuretic use
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure (AHF) and Decompensated Chronic Heart Failure, run by Aarhus University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristoffer Berg-Hansen, MD, PhD (+4560540700, krisbe@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of heart failure readmission and all-cause mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.