Investigating aCute heArt failuRe Decongestion Guided by Lung

Status Not yet recruiting

Clinical Trial Summary

The goal of this clinical trial is to investigate if a lung ultrasonography (LUS)- guided decongestion strategy in adults hospitalized for acute heart failure (AHF) can improve patient-centered early outcomes. The main questions it aims to answer are: - Does this strategy shorten lenght of stay and reduce early hospital readmission? - Does this strategy improve patients' quality of life ? Researchers will compare LUS to physical examination (PE).

Clinical Trial Description

Background: Despite recent medical advances, acute heart failure (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. Lung ultrasonography (LUS) has highly accurate for the detection of extravascular lung water (EVLW). It has shown clinical benefits when used for decongestive therapy guidance in chronic HF ambulatory patients. For AHF inpatients data are currently lacking. Aim: To investigate the effect of a simple bedside LUS-protocol-guided decongestive therapy in hospitalized AHF adults on patient-centered outcomes (hospital length of stay, readmission, urgent visits, and mortality), as compared to usual care. Methodology: This will be a Swiss multicentric blinded randomized controlled trial (RCT) aiming to recruit 222 adults hospitalized for congestive AHF. Study participants will be included in the first 48 hours following their hospital arrival. Patients will be randomized to a LUS-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 in a 40-day timeframe from study inclusion (DAOH-40). This outcome integrates length of stay, early readmission, ER urgent visits and mortality. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06465498
Study type	Interventional
Source	University Hospital, Geneva
Contact
Status	Not yet recruiting
Phase	N/A
Start date	September 15, 2024
Completion date	August 30, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography — IcarUS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms