Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography (IcarUS) : a Randomized Controlled Trial
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥ 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).
Locations
Other Locations
Switzerland
Inselspital, Universitätspital
RECRUITING
Bern
Fribourg University Hospital
RECRUITING
Fribourg
Geneva University Hospitals
RECRUITING
Geneva
Ospedale Civico, Ente Ospedaliero Cantonale
NOT_YET_RECRUITING
Lugano
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 222
Treatments
Experimental: Lung ultrasonography (LUS)
The antero-lateral thorax is examined using an 8-point protocol. Each region is coded positive in presence of ≥3 B-lines simultaneously on a frozen image or in presence of significant pleural effusion (i.e. extending over the costophrenic angle). A 4-level congestion score is defined: absence of congestion (0-1 positive points), mild congestion (2-3 positive points), moderate congestion (4-5 positive points) and severe congestion (6-8 positive points).
Active_comparator: Physical Examination (PE)
Congestion is clinically assessed by calculating the Everest score. This score, previously used in clinical trials, is composed of 3 congestion symptoms (i.e. dyspnea, orthopnoea and fatigue) and 3 congestion signs (i.e. jugular vein distension, lung rales, oedema), each graded from 0 to 3. From the total score, a sub-score is derived, ranging from absence of congestion to severe congestion.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Geneva
Leads: Antonio Leidi