IcarUS - study investigating the utility of pleuropulmonary ultrasound as a guide for diuretic treatment in cases of acute heart failure.
Descrizione riassuntiva dello studio
Despite significant therapeutic advances, patients suffering from acute heart failure continue to experience prolonged hospital stays and high readmission rates. These phenomena are particularly attributable to the limited performance of clinical examination in accurately assessing the signs of acute heart failure, especially those related to water-sodium retention (or congestion). Targeted ultrasound has better diagnostic performance and is particularly sensitive for detecting pulmonary congestion. Recent data show that its use as a guide for decongestive treatment in the outpatient follow-up of patients with chronic heart failure reduces the hospitalization rate at 90 days. However, there is little data on its utility in managing patients in the hospital. The IcarUS research project aims to evaluate the impact of using a pleuropulmonary ultrasound-guided management protocol in hospitalized patients with acute heart failure on their length of stay and risk of hospital readmission. This scientific approach is part of a Swiss multicenter randomized controlled clinical trial. In the context of the trial, neither the attending physician nor the patient knows whether their treatment is guided by ultrasound or clinical examination. The primary objective of the study is to see if this approach allows for an increase in days spent at home, by reducing the length of hospital stay and a lower readmission rate in the month following discharge.
(BASEC)
Intervento studiato
Pleuropulmonary ultrasound as a guide for diuretic treatment
(BASEC)
Malattie studiate
Acute heart failure
(BASEC)
Hospitalized adults with a diagnosis of heart failure decompensation (BASEC)
Criteri di esclusione
Hypotension at inclusion (<90 mmHg or <65 mmHg systolic or mean blood pressure respectively); Pregnancy or breastfeeding; Allergy to diuretic treatment (BASEC)
Luogo dello studio
Berna, Friburgo, Ginevra, Lugano
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Antonio Leidi
+41 22 37 29 205
Antonio.Leidi@clutterhcuge.ch(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ginevra
(BASEC)
Data di approvazione del comitato etico
16.09.2024
(BASEC)
ID di studio ICTRP
NCT06465498 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography (IcarUS) : a Randomized Controlled Trial (ICTRP)
Titolo pubblico
Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography (ICTRP)
Malattie studiate
Acute Heart Failure (ICTRP)
Intervento studiato
Procedure: LUS decongestive strategyProcedure: PE decongestive strategy (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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 (ICTRP)
non disponibile
Endpoint primari e secondari
DAOH-40 (ICTRP)
Successful decongestion;Diuretic dose;EQ-5D-5L questionary;Readmission and any-cause mortality;HF-related hospitalisation;Length of hospital stay;Dyspnea;Anxiety and depression (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University Hospital, Geneva (ICTRP)
Contatti aggiuntivi
Antonio Leidi, MD, Antonio.Leidi@hug.ch, +41223729101 (ICTRP)
ID secondari
2024-00268 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06465498 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile