Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography (IcarUS)

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Heart Failure
• Intervention / Treatment: Procedure: LUS decongestive strategy; Procedure: PE decongestive strategy

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 Type: Interventional
• Enrollment (Estimated): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Fribourg, Switzerland
    • Recruiting
    • Fribourg University Hospital
    • Contact: Fernando Esposito; Phone Number: +41 26 306 23 64; Email: Fernando.Esposito@hfr.ch
  • Lugano, Switzerland
    • Terminated
    • Ospedale Civico, Ente Ospedaliero Cantonale
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1205
      • Recruiting
      • Geneva University Hospitals
      • Contact: Antonio Leidi, MD; Phone Number: +41223729101; Email: Antonio.Leidi@hug.ch
    • Geneva, Canton of Geneva, Switzerland, 1204
      • Recruiting
      • Trois-Chêne Hospital, Geneva Univesity Hospitals
      • Contact: Thibault Parent, Dr; Phone Number: +41 79 55 38 856; Email: thibault.parent@hug.ch
  • Switzerland
    • Bern, Switzerland, Switzerland
      • Recruiting
      • Inselspital, Universitätspital
      • Contact: Claudio Schneider; Phone Number: +41 31 632 21 11; Email: claudio.schneider@insel.ch

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• ≥ 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lung ultrasonography (LUS); 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).	Procedure: LUS decongestive strategy; 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.
Active Comparator: Physical Examination (PE); 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.	Procedure: PE decongestive strategy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	40 days from study inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 working days after randomization
Diuretic dose	Mean daily dose of diuretic therapy during study intervention (in furosemide iv equivalent)	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.	Up to 90 days after discharge
Readmission and any-cause mortality	Rate of hospital readmissions and deaths occurring within 90 days of discharge	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	Up to 90 days after discharge
Length of hospital stay	Mean length of hospital stay	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.	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.	Up to 90 days after discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worsening of renal function	≥50% rise of serum creatinine from baseline value	Up to 6 working days after randomisation
Hyponatremia	Rate of severe hyponatremia <120 mmol/l	Up to 6 working days after randomisation
Hypokaliemia	Rate of severe hypokaliemia <2.5 mmol/l	Up to 6 working days after randomisation
Sustained hypotension	proportion of patients needing vasopressor/inotropic agents because of sustained hypotension	Up to 6 working days after randomisation

Collaborators and Investigators

• Sponsor: Antonio Leidi
• Collaborators: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Diuretic; Decongestion; Lung ultrasonography; Point-of-care ultrasonography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2024-00268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No