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NCT Number: NCT06465498

Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography

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).

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Key information

Conditions

Acute Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals, Geneva, Canton of Geneva, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LUS decongestive strategy

Procedure

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 strategy

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Successful decongestion

    Time frame: 3 working days after randomization

    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.

  2. Diuretic dose

    Time frame: Uo to 6 working days after randomisation

    Mean daily dose of diuretic therapy during study intervention (in furosemide iv equivalent)

  3. EQ-5D-5L questionary

    Time frame: Up to 90 days after discharge

    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.

  4. Readmission and any-cause mortality

    Time frame: Up to 90 days after discharge

    Rate of hospital readmissions and deaths occurring within 90 days of discharge

  5. HF-related hospitalisation

    Time frame: Up to 90 days after discharge

    Rate of HF-related hospitalisation, as defined by the presence of worsening signs and symptoms of HF and an intensification of the diuretic therapy

  6. Length of hospital stay

    Time frame: Through hospitalization, an average of 9 days

    Mean length of hospital stay

  7. Dyspnea

    Time frame: Up to 90 days after discharge

    Dyspnea assessed with a 100-mm Visual Analog Scale (VAS), score ranging from 0 to 100, higher scores mean worse outcome.

  8. Anxiety and depression

    Time frame: Up to 90 days after discharge

    Hospital Anxiety and Depression Scale, two subscales ranging from 0 to 21 points, higher scores mean worse outcome.

Other outcomes

  1. Worsening of renal function

    Time frame: Up to 6 working days after randomisation

    ≥50% rise of serum creatinine from baseline value

  2. Hyponatremia

    Time frame: Up to 6 working days after randomisation

    Rate of severe hyponatremia <120 mmol/l

  3. Hypokaliemia

    Time frame: Up to 6 working days after randomisation

    Rate of severe hypokaliemia <2.5 mmol/l

  4. Sustained hypotension

    Time frame: Up to 6 working days after randomisation

    proportion of patients needing vasopressor/inotropic agents because of sustained hypotension

Sponsors and collaborators

Lead sponsor

Antonio Leidi

Other

Collaborators

  • University Hospital, Geneva

Registry information

Official study title

Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography (IcarUS) : a Randomized Controlled Trial

Acronym: IcarUS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 20, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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