Ignite Creation Date:
2024-07-17 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465498
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-13
Brief Title:
Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography
Sponsor:
Antonio Leidi
Organization:
University Hospital Geneva
Study Overview
Official Title:
Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography IcarUS a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IcarUS
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None