NCT06465498

Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Antonio Leidi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-22
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2024-06-20
• Last updated: 2026-04-01

Locations

5 sites across 1 country: Switzerland