Clinical trial NCT06465498: Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography
Official title: Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography (IcarUS) : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Heart Failure
Keywords: Lung ultrasonography
Ultrasound
Point-of-care ultrasonography
Decongestion
Diuretic
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2024-06-20
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric blinded randomized controlled trial (RCT)
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Planned or actual 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
* The following conditions mimicking lung cardiogenic oedema on LUS if known at inclusion and documented: Interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion
* Known virologically confirmed SARS-CoV-2 pneumonia in the preceding 3 months
* Unwillingness to give consent
* Subjects who are pregnant or breastfeeding
* Hospitalisation for palliative care and probable end-life within 30 days

Primary outcomes:
measure: DAOH-40
timeFrame: 40 days from study inclusion
Secondary outcomes:
measure: Successful decongestion
timeFrame: 3 working days after randomization
measure: Diuretic dose
timeFrame: Uo to 6 working days after randomisation
measure: EQ-5D-5L questionary
timeFrame: Up to 90 days after discharge
measure: Readmission and any-cause mortality
timeFrame: Up to 90 days after discharge
measure: HF-related hospitalisation
timeFrame: Up to 90 days after discharge
measure: Length of hospital stay
timeFrame: Through hospitalization, an average of 9 days
measure: Dyspnea
timeFrame: Up to 90 days after discharge
measure: Anxiety and depression
timeFrame: Up to 90 days after discharge
Other outcomes:
measure: Worsening of renal function
timeFrame: Up to 6 working days after randomisation
measure: Hyponatremia
timeFrame: Up to 6 working days after randomisation
measure: Hypokaliemia
timeFrame: Up to 6 working days after randomisation
measure: Sustained hypotension
timeFrame: Up to 6 working days after randomisation
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Universitätspital
city: Fribourg
country: Switzerland
facility: Fribourg University Hospital
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
city: Lugano
country: Switzerland
facility: Ospedale Civico, Ente Ospedaliero Cantonale
Study officials:
References: