Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography

Acute Heart Failure Clinical Trial

— IcarUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465498
• Other study ID #: 2024-00268
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2024
• Est. completion date: August 30, 2026

Study information

• Verified date: June 2024
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 222
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old
• Planned 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
• Unwillingness to give consent
• Subjects who are pregnant or breastfeeding
• Hospitalisation for palliative care and probable end-life within 30 days

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Procedure:
• Decongestion strategy
LUS (intervention arm) and PE (control arm) results are documented in the eCRF and one of them is 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 of stepping-up, maintaining or stepping-down the decongestive therapy.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Antonio Leidi

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAOH-40	Number of days spent alive outside the hospital in a 40-day timeframe from study inclusion. This outcome integrates length of stay, early readmission, unplanned emergency or outpatient visits and mortality.	40 days from study inclusion
Secondary	Successful decongestion	Proportion of participants obtaining successful decongestion (i.e absence of signs of volume overload as defined by the ADVOR congestion score)	3 working days after randomization
Secondary	Diuretic dose	Mean daily dose of diuretic therapy during hospital stay (in furosemide iv equivalent)	A maximum of 6 working days after randomization
Secondary	Anxiety and depression	Hospital Anxiety and Depression Scale	40 days from study inclusion
Secondary	EQ-5D-5L questionary	Quality of life questionary	40 days from study inclusion