Acute Heart FailureIcarUSNCT06465498
Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography
A study testing LUS decongestive strategy and PE decongestive strategy in people with Acute Heart Failure, run by Antonio Leidi at 5 sites in Switzerland.
Trial summary
The goal of this clinical trial is to investigate whether a lung ultrasonography (LUS)-guided decongestion strategy in adults hospitalized for acute heart failure (AHF) can improve patient-centered outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- LUS decongestive strategy and PE decongestive strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 22 Oct 2024to 30 Apr 2027
- Phase
- Interventional
- 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
Who may be able to join
- ≥ 18 years old
- Planned or actual admission to intermediate care units, general internal medical or cardiology wards
- Diagnosis of congestive AHF on admission chart (primary or secondary diagnosis)
- Raised value of N terminal-pro-brain natriuretic peptide (≥1000 ng/l).
Who cannot join
- Known isolated right heart failure
- Systolic blood pressure <90 mmHg, mean arterial pressure <65 mmHg at the moment of inclusion
- The following conditions mimicking lung cardiogenic oedema on LUS if known at inclusion and documented: Interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion
- Known virologically confirmed SARS-CoV-2 pneumonia in the preceding 3 months
- Unwillingness to give consent
- Subjects who are pregnant or breastfeeding
- Hospitalisation for palliative care and probable end-life within 30 days
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Switzerland5 sites, 4 recruiting
- Recruiting
Inselspital, Universitätspital
Bern, Switzerland
Claudio Schneider, +41 31 632 21 11, claudio.schneider@insel.ch
- Recruiting
Fribourg University Hospital
Fribourg
Fernando Esposito, +41 26 306 23 64, Fernando.Esposito@hfr.ch
- Recruiting
Trois-Chêne Hospital, Geneva Univesity Hospitals
Geneva, Canton of Geneva, 1204
Thibault Parent, Dr, +41 79 55 38 856, thibault.parent@hug.ch
- Recruiting
Geneva University Hospitals
Geneva, Canton of Geneva, 1205
Antonio Leidi, MD, +41223729101, Antonio.Leidi@hug.ch
- Terminated
Ospedale Civico, Ente Ospedaliero Cantonale
Lugano
About this study
Official title: Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography (IcarUS) : a Randomized Controlled Trial
The goal of this clinical trial is to investigate whether a lung ultrasonography (LUS)-guided decongestion strategy in adults hospitalized for acute heart failure (AHF) can improve patient-centered outcomes.
The main questions it aims to answer are:
- Does this strategy shorten the length of stay and reduce early hospital readmissions?
- Does this strategy improve patients' symptoms and quality of life ?
Researchers will compare LUS to physical examination (PE).
Read the detailed description
Background: Despite recent medical advances, AHF remains one of the leading causes of hospital admissions and one of the most frequent reasons for readmission. As the main reason for AHF hospitalization is congestion-driven symptoms, the cornerstone of treatment is decongestive therapy. In the absence of specific quantitative measures, however, undertreatment often occurs and is associated with an increased risk of readmission. LUS is highly accurate for detecting extravascular lung water (EVLW). It has shown clinical benefits when used to guide decongestive therapy in chronic heart failure ambulatory patients. However, data for its use in AHF inpatients are currently lacking.
Aim: To investigate the effect of a bedside LUS-guided decongestive therapy in hospitalized AHF adults on patient-centered outcomes, as compared to usual care.
Methodology: This will be a Swiss multicenter, blinded, randomized controlled trial (RCT) aiming to recruit 222 adults hospitalized for congestive acute heart failure (AHF). Study participants will be included within the first 48 hours of their hospital arrival. Patients will be randomized to either a LUS-guided decongestive strategy or a decongestive strategy based on a structured physical examination. The primary outcome will be the number of days spent alive outside the hospital within a 40-day timeframe from study inclusion (DAOH-40). This outcome integrates length of stay, early readmission, emergency room visits, and mortality.
- Conditions
- Acute Heart Failure
- Being tested
- LUS decongestive strategy, PE decongestive strategy
- Keywords
- Lung ultrasonography, Ultrasound, Point-of-care ultrasonography, Decongestion, Diuretic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUS decongestive strategyProcedure or surgery
LUS results are documented in the electronic case report form (eCRF) and converted into a common score ranging from absence of congestion to severe congestion. This generic congestion score will be communicated to the treating physician by the research personnel, along with a proposal to step-up, maintain, or step-down the decongestive therapy.
PE decongestive strategyProcedure or surgery
PE results are documented in the eCRF and converted into a common score ranging from absence of congestion to severe congestion. This generic congestion score will be communicated to the treating physician by the research personnel, along with a proposal to step-up, maintain, or step-down the decongestive therapy.
| Study group | Role | What they receive |
|---|---|---|
| Lung ultrasonography (LUS) | Experimental | The antero-lateral thorax is examined using an 8-point protocol. Each region is coded positive in presence of ≥3 B-lines simultaneously on a frozen image or in presence of significant pleural effusion (i.e. extending over the costophrenic angle). A 4-level congestion score is defined: absence of congestion (0-1 positive points), mild congestion (2-3 positive points), moderate congestion (4-5 positive points) and severe congestion (6-8 positive points). Receives: Procedure: LUS decongestive strategy |
| Physical Examination (PE) | Active comparator | Congestion is clinically assessed by calculating the Everest score. This score, previously used in clinical trials, is composed of 3 congestion symptoms (i.e. dyspnea, orthopnoea and fatigue) and 3 congestion signs (i.e. jugular vein distension, lung rales, oedema), each graded from 0 to 3. From the total score, a sub-score is derived, ranging from absence of congestion to severe congestion. Receives: Procedure: PE decongestive strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAOH-40
Number of days spent alive outside the hospital in a 40-day timeframe from study inclusion.
This outcome ultimately evaluates number of days spent alive and nonhospitalized, simultaneously assessing (re)hospitalization, unplanned emergency visits and mortality
Measured: 40 days from study inclusion
Secondary outcomes (8)
Successful decongestion
Proportion of participants obtaining successful decongestion, i.e the absence of signs of volume overload as defined by the Acetazolamide in Decompensated Heart Failure with Volume Overload (ADVOR) congestion score.
Measured: 3 working days after randomization
Diuretic dose
Mean daily dose of diuretic therapy during study intervention (in furosemide iv equivalent)
Measured: Uo to 6 working days after randomisation
EQ-5D-5L questionary
Quality of life questionary. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Measured: Up to 90 days after discharge
Readmission and any-cause mortality
Rate of hospital readmissions and deaths occurring within 90 days of discharge
Measured: Up to 90 days after discharge
HF-related hospitalisation
Rate of HF-related hospitalisation, as defined by the presence of worsening signs and symptoms of HF and an intensification of the diuretic therapy
Measured: Up to 90 days after discharge
Length of hospital stay
Mean length of hospital stay
Measured: Through hospitalization, an average of 9 days
Dyspnea
Dyspnea assessed with a 100-mm Visual Analog Scale (VAS), score ranging from 0 to 100, higher scores mean worse outcome.
Measured: Up to 90 days after discharge
Anxiety and depression
Hospital Anxiety and Depression Scale, two subscales ranging from 0 to 21 points, higher scores mean worse outcome.
Measured: Up to 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start22 Oct 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric blinded randomized controlled trial (RCT)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonio Leidi
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Antonio Leidi, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465498
- Sponsor's protocol ID
- 2024-00268
- Acronym
- IcarUS
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leidi A, Mann T, Gosselin P, Bedulli M, Esposito F, Schneider C, Parent T, Combescure C, Desmettre T, Reny JL, Stirnemann J, Grosgurin O; ICARUS study group. The ICARUS project: study protocol for a randomised controlled trial Investigating aCute heArt failuRe decongestion guided by lung UltraSonography. Trials. 2026 Apr 22;27(1):414. doi: 10.1186/s13063-026-09701-8.
PubMed 42021403
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography (IcarUS) : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06465498
- Acronym / sponsor ID
- IcarUS / 2024-00268
- Conditions
- Acute Heart Failure
- Keywords
- Lung ultrasonography, Ultrasound, Point-of-care ultrasonography, Decongestion, Diuretic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Antonio LeidiUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 20 Jun 2024 (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.
The goal of this clinical trial is to investigate whether a lung ultrasonography (LUS)-guided decongestion strategy in adults hospitalized for acute heart failure (AHF) can improve patient-centered outcomes.
The main questions it aims to answer are:
- Does this strategy shorten the length of stay and reduce early hospital readmissions?
- Does this strategy improve patients' symptoms and quality of life ?
Researchers will compare LUS to physical examination (PE).
Detailed description
Background: Despite recent medical advances, AHF remains one of the leading causes of hospital admissions and one of the most frequent reasons for readmission. As the main reason for AHF hospitalization is congestion-driven symptoms, the cornerstone of treatment is decongestive therapy. In the absence of specific quantitative measures, however, undertreatment often occurs and is associated with an increased risk of readmission. LUS is highly accurate for detecting extravascular lung water (EVLW). It has shown clinical benefits when used to guide decongestive therapy in chronic heart failure ambulatory patients. However, data for its use in AHF inpatients are currently lacking.
Aim: To investigate the effect of a bedside LUS-guided decongestive therapy in hospitalized AHF adults on patient-centered outcomes, as compared to usual care.
Methodology: This will be a Swiss multicenter, blinded, randomized controlled trial (RCT) aiming to recruit 222 adults hospitalized for congestive acute heart failure (AHF). Study participants will be included within the first 48 hours of their hospital arrival. Patients will be randomized to either a LUS-guided decongestive strategy or a decongestive strategy based on a structured physical examination. The primary outcome will be the number of days spent alive outside the hospital within a 40-day timeframe from study inclusion (DAOH-40). This outcome integrates length of stay, early readmission, emergency room visits, and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentric blinded randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Lung ultrasonography (LUS) | Experimental | Procedure: LUS decongestive strategyThe antero-lateral thorax is examined using an 8-point protocol. Each region is coded positive in presence of ≥3 B-lines simultaneously on a frozen image or in presence of significant pleural effusion (i.e. extending over the costophrenic angle). A 4-level congestion score is defined: absence of congestion (0-1 positive points), mild congestion (2-3 positive points), moderate congestion (4-5 positive points) and severe congestion (6-8 positive points). |
| Physical Examination (PE) | Active comparator | Procedure: PE decongestive strategyCongestion is clinically assessed by calculating the Everest score. This score, previously used in clinical trials, is composed of 3 congestion symptoms (i.e. dyspnea, orthopnoea and fatigue) and 3 congestion signs (i.e. jugular vein distension, lung rales, oedema), each graded from 0 to 3. From the total score, a sub-score is derived, ranging from absence of congestion to severe congestion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years old
- Planned or actual admission to intermediate care units, general internal medical or cardiology wards
- Diagnosis of congestive AHF on admission chart (primary or secondary diagnosis)
- Raised value of N terminal-pro-brain natriuretic peptide (≥1000 ng/l).
Key exclusion criteria (7 listed)
- Known isolated right heart failure
- Systolic blood pressure <90 mmHg, mean arterial pressure <65 mmHg at the moment of inclusion
- The following conditions mimicking lung cardiogenic oedema on LUS if known at inclusion and documented: Interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion
- Known virologically confirmed SARS-CoV-2 pneumonia in the preceding 3 months
- Unwillingness to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUS decongestive strategyLUS results are documented in the electronic case report form (eCRF) and converted into a common score ranging from absence of congestion to severe congestion. This generic congestion score will be communicated to the treating physician by the research personnel, along with a proposal to step-up, maintain, or step-down the decongestive therapy. | Procedure or surgery | Lung ultrasonography (LUS) |
| PE decongestive strategyPE results are documented in the eCRF and converted into a common score ranging from absence of congestion to severe congestion. This generic congestion score will be communicated to the treating physician by the research personnel, along with a proposal to step-up, maintain, or step-down the decongestive therapy. | Procedure or surgery | Physical Examination (PE) |
Primary outcome
DAOH-40
Time frame: 40 days from study inclusion
Number of days spent alive outside the hospital in a 40-day timeframe from study inclusion. This outcome ultimately evaluates number of days spent alive and nonhospitalized, simultaneously assessing (re)hospitalization, unplanned emergency visits and mortality
8 secondary outcomes
Successful decongestion
Time frame: 3 working days after randomization
Diuretic dose
Time frame: Uo to 6 working days after randomisation
EQ-5D-5L questionary
Time frame: Up to 90 days after discharge
Readmission and any-cause mortality
Time frame: Up to 90 days after discharge
HF-related hospitalisation
Time frame: Up to 90 days after discharge
Length of hospital stay
Time frame: Through hospitalization, an average of 9 days
Dyspnea
Time frame: Up to 90 days after discharge
Anxiety and depression
Time frame: Up to 90 days after discharge
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 1 Apr 2026.
- Derived from this study: PubMed 42021403Leidi A, Mann T, Gosselin P, Bedulli M, Esposito F, Schneider C, Parent T, Combescure C, Desmettre T, Reny JL, Stirnemann J, Grosgurin O; ICARUS study group. The ICARUS project: study protocol for a randomised controlled trial Investigating aCute heArt failuRe decongestion guided by lung UltraSonography. Trials. 2026 Apr 22;27(1):414. doi: 10.1186/s13063-026-09701-8.
- Individual participant dataSharing planned: No
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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.
Trois-Chêne Hospital, Geneva Univesity Hospitals
Geneva, Switzerland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUS decongestive strategy and PE decongestive strategy in people with Acute Heart Failure, run by Antonio Leidi at 5 sites in Switzerland.
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 4 inclusion and 7 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAOH-40 (time frame: 40 days from study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06465498, which also lists 1 linked publication.
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 1 Apr 2026.