Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• DAOH-40 [Time frame: 40 days from study inclusion]

Secondary outcome measures (8)

• 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]

Eligibility criteria

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).

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Switzerland · 5 centers

• Trois-Chêne Hospital, Geneva Univesity Hospitals — Geneva
• Geneva University Hospitals — Geneva
• Inselspital, Universitätspital — Bern
• Fribourg University Hospital — Fribourg
• Ospedale Civico, Ente Ospedaliero Cantonale — Lugano

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. PMID 42021403

Identifiers

NCT: NCT06465498 · 2024-00268

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗