IcarUS - study investigating the utility of pleuropulmonary ultrasound as a guide for diuretic treatment in cases of acute heart failure.
Zusammenfassung der Studie
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)
Untersuchte Intervention
Pleuropulmonary ultrasound as a guide for diuretic treatment
(BASEC)
Untersuchte Krankheit(en)
Acute heart failure
(BASEC)
Hospitalized adults with a diagnosis of heart failure decompensation (BASEC)
Ausschlusskriterien
Hypotension at inclusion (<90 mmHg or <65 mmHg systolic or mean blood pressure respectively); Pregnancy or breastfeeding; Allergy to diuretic treatment (BASEC)
Studienstandort
Bern, Freiburg, Genf, Lugano
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
16.09.2024
(BASEC)
ICTRP Studien-ID
NCT06465498 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography (IcarUS) : a Randomized Controlled Trial (ICTRP)
Öffentlicher Titel
Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography (ICTRP)
Untersuchte Krankheit(en)
Acute Heart Failure (ICTRP)
Untersuchte Intervention
Procedure: LUS decongestive strategyProcedure: PE decongestive strategy (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University Hospital, Geneva (ICTRP)
Weitere Kontakte
Antonio Leidi, MD, Antonio.Leidi@hug.ch, +41223729101 (ICTRP)
Sekundäre IDs
2024-00268 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06465498 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar