Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography
NCT Number: NCT06465498
Acronym: IcarUS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Heart Failure
Interventions: PROCEDURE: LUS decongestive strategy|PROCEDURE: PE decongestive strategy
Sponsor: Antonio Leidi
Collaborators: University Hospital, Geneva
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 222
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2026-08-30
Locations: Geneva University Hospitals, Geneva, 1205, Switzerland

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).

Primary Outcome Measures: DAOH-40, Number of days spent alive outside the hospital in a 40-day timeframe from study inclusion.

This outcome ultimately evaluates number of days spent alive and nonhospitalized, simultaneously assessing (re)hospitalization, unplanned emergency visits and mortality, 40 days from study inclusion
Secondary Outcome Measures: Successful decongestion, Proportion of participants obtaining successful decongestion, i.e the absence of signs of volume overload as defined by the Acetazolamide in Decompensated Heart Failure with Volume Overload (ADVOR) congestion score., 3 working days after randomization|Diuretic dose, Mean daily dose of diuretic therapy during study intervention (in furosemide iv equivalent), Uo to 6 working days after randomisation|EQ-5D-5L questionary, Quality of life questionary. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state., Up to 90 days after discharge|Readmission and any-cause mortality, Rate of hospital readmissions and deaths occurring within 90 days of discharge, Up to 90 days after discharge|HF-related hospitalisation, Rate of HF-related hospitalisation, as defined by the presence of worsening signs and symptoms of HF and an intensification of the diuretic therapy, Up to 90 days after discharge|Length of hospital stay, Mean length of hospital stay, Through hospitalization, an average of 9 days|Dyspnea, Dyspnea assessed with a 100-mm Visual Analog Scale (VAS), score ranging from 0 to 100, higher scores mean worse outcome., Up to 90 days after discharge|Anxiety and depression, Hospital Anxiety and Depression Scale, two subscales ranging from 0 to 21 points, higher scores mean worse outcome., Up to 90 days after discharge
Other Outcome Measures: Worsening of renal function, ≥50% rise of serum creatinine from baseline value, Up to 6 working days after randomisation|Hyponatremia, Rate of severe hyponatremia \<120 mmol/l, Up to 6 working days after randomisation|Hypokaliemia, Rate of severe hypokaliemia \<2.5 mmol/l, Up to 6 working days after randomisation|Sustained hypotension, proportion of patients needing vasopressor/inotropic agents because of sustained hypotension, Up to 6 working days after randomisation