The ICARUS project : study protocol for a randomised controlled trial Investigating aCute heArt failuRe decongestion guided by lung UltraSonography

Article Article scientifique Article The ICARUS project : study protocol for a randomised controlled trial Investigating aCute heArt failuRe decongestion guided by lung UltraSonography eng 2026-04-22 author Leidi Antonio Siro Gabriele 0000-0002-3934-0104 General Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. Antonio.Leidi@hug.ch.,Emergency Medicine, Department of Acute Medicine, Geneva University Hospitals, Geneva, Switzerland. Antonio.Leidi@hug.ch. 910614 author Mann Tamara General Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. author Gosselin Pauline General Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. 804518 author Bedulli Michele Division of Internal Medicine, Ente Ospedaliero Cantonale, Lugano, Switzerland. author Esposito Fernando Division of Internal Medicine, Fribourg Cantonal Hospital, Fribourg, Switzerland. author Schneider Claudio General Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.,General Internal Medicine, Department of Medicine, Inselspital University Hospital, Bern, Switzerland. author Parent Thibault Division of Internal Medicine for the Aged, Geneva University Hospitals, Geneva, Switzerland. 928048 author Combescure Christophe 0000-0003-2631-4780 Clinical Research Centre & Division of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva & Geneva University Hospitals, Geneva, Switzerland. 670542 Département de santé et médecine communautaire (MECOM) author Desmettre Thibaut Emergency Medicine, Department of Acute Medicine, Geneva University Hospitals, Geneva, Switzerland.,Department of Anaesthesiology, Intensive Care and Emergency Medicine, Faculty of Medicine, University of Geneva, PharmacologyGeneva, Switzerland. 412936 Département d'anesthésiologie, pharmacologie et soins intensifs (APSIC) author Reny Jean-Luc 0000-0002-7528-7363 General Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. 704339 Département de médecine (DEMED) author Stirnemann Jérôme General Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. 793435 Département de médecine (DEMED) author Grosgurin Olivier General Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.,Emergency Medicine, Department of Acute Medicine, Geneva University Hospitals, Geneva, Switzerland. 503200 Département de médecine (DEMED) ICARUS study group collaborator Abdou Garonne Laëtitia 443977 Département de médecine génétique et développement (GEDEV) collaborator Aellen Gwaenaelle collaborator Andreoli Gauthier 753723 collaborator Aubert Carole 45043 collaborator Bettini Luca Davide 975157 collaborator Bex Stijn Frans D 848655 Stijn Bex collaborator Bonnet Romain collaborator Bopp Tara Lydia 704375 collaborator Bovio Emanuele collaborator Bruno Giovanni collaborator Canonica Simone collaborator Carballo Juan Sebastian 0000-0002-8344-4293 84409 Département de médecine (DEMED) collaborator Cerutti Alberto collaborator Marti Christophe Alberic 97449 Département de médecine (DEMED) collaborator Coen Matteo 0000-0002-6156-1691 601519 Département de médecine (DEMED) collaborator Costantini Luisa collaborator Dash Jonathan 675275 collaborator Ferrazzini Elisa collaborator Foucras Sandrine collaborator Gloor Manuel collaborator Grandmaison Gael collaborator Grassi Nadia collaborator Guijarro Damien 419468 collaborator Serratrice Jacques 836481 Département de médecine (DEMED) collaborator Juillerat André 671488 collaborator Priore Elia Lo collaborator Lopez Karine 90741 collaborator Luder Joël 584266 collaborator Mancinetti Marco collaborator Mantelli Sophie collaborator Marketa Gabriel collaborator Marti René Andréas 70986 collaborator Marx Caterina Eva collaborator Maurer Simona collaborator Meyer Philippe 48187 Département de médecine (DEMED) collaborator Morosoli Lara collaborator Moschovitis Giorgio collaborator Mugetti Elisa collaborator Peier Franziska collaborator Pernoud Caroline collaborator Pianezzi-Chappex Nina collaborator Piller Vincent 725447 collaborator Potinc Oana collaborator Pulver Damiana collaborator Puricel Serban-George collaborator Rime Martine collaborator Rimensberger Caroline collaborator Rochat Mathilde collaborator Schmutz Maxime collaborator Soret Guillaume 669645 collaborator Sutter Nora collaborator Trachsel Maria collaborator Trinci Guido collaborator Tschan Salome collaborator Valiton Valerian 659987 collaborator Von Allmen Annina 10.1186/s13063-026-09701-8 42021403 1745-6215 Background: Acute congestive heart failure (AHF) is a leading cause of hospital admission, with decongestion serving as the cornerstone of its treatment. In the absence of congestion-specific quantitative measures, however, undertreatment often occurs and it is associated with an increased risk of readmission. Lung ultrasonography (LUS) has high accuracy for detecting extravascular lung water. Its use for guiding decongestion in ambulatory patients has shown a reduction in hospital admission and urgent outpatient visits, whereas data are lacking for AHF inpatients. Our aim is to investigate the effect of a LUS-guided decongestive therapy on early clinical outcomes, as compared to physical examination, in hospitalised AHF adults. Methods: The ICARUS project is a multicentric, multi-blinded, randomised, controlled superiority study, aiming to recruit 222 adult, hospitalised AHF patients with raised values of natriuretic peptide. Participants will be randomised to a decongestive strategy guided by either daily LUS findings (8-point protocol) or daily physical examination. The randomisation will be stratified by study centre and inclusion delay (i.e. within 24 h or more). The primary outcome is the number of days spent alive and out of hospital in a 40-day timeframe from study inclusion (DAOH-40). Secondary outcomes include successful decongestion, length of hospital stay (index hospitalisation), early readmission and mortality, dyspnoea and quality of life (EQ-5D-5L). Discussion: Incomplete decongestion at discharge is frequent in patients hospitalised for AHF and it is strongly associated with rehospitalisation and mortality. There is a need to clarify the role of LUS as a guide for decongestive therapies. The ICARUS project will provide strong evidence on the usefulness of LUS as a guide for decongestive therapy in hospitalised AHF patients. Trial registration: The present protocol is registered in ClinicalTrials.gov (NCT06465498, registered 20 June 2024, https://clinicaltrials.gov/study/NCT06465498) and in the Swiss human research platform HumRes of the Federal Office of Public Health (CCER 2024-00268). Congestion Decongestion Diuretic Heart failure Lung ultrasonography Ultrasound Dewey 616 Dewey 617 Dewey 618.97 Dewey 618 63 Département d'anesthésiologie, pharmacologie, soins intensifs et urgences 229 56 Département de médecine 221 65 Département de réadaptation et gériatrie 22B 217 Centre de recherche clinique 201 false 88 Epidémiologie clinique et biostatistique 115 11 Plaquettes et antithrombotiques 13 319 Groupe Perrier Arnaud (Médecine interne générale, de réhabilitation et de gériatrie) 585 Trials 5d8b6dac-8672-4d16-b5c5-460b1f4a30a3 Article (Accepted version) Public s13063-026-09701-8_reference.pdf 1438790 application/pdf CC BY-NC-ND-4.0 9660fdbbf27510fc977cbb6a6d29a85c20357541ffd8626d4f2a53d36d766651 82a73acd-f6ca-4c7a-92c6-cc650f96d187 Supplemental data Public 13063_2026_9701_MOESM1_ESM.docx 40628 application/vnd.openxmlformats-officedocument.wordprocessingml.document 14035fd8a7118c2375851d18997aa677f961356e783b3c7bfa09aa7e3faa242e openAccess Faculté de médecine / Section de médecine clinique / Département d'anesthésiologie, pharmacologie, soins intensifs et urgences Faculté de médecine / Section de médecine clinique / Département de médecine Faculté de médecine / Section de médecine clinique / Département de réadaptation et gériatrie Faculté de médecine / Centre de recherche clinique

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