An interventional study of LUS decongestive strategy and PE decongestive strategy in Acute Heart Failure, sponsored by Antonio Leidi. Recruiting at 5 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Antonio Leidi · Not applicable, Interventional, and Treatment
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:
Researchers will compare LUS to physical examination (PE).
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.
This is the only study on the registry with Antonio Leidi as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Key Exclusion Criteria:
The antero-lateral thorax is examined using an 8-point protocol. Each region is coded positive in presence of ≥3 B-lines simultaneously on a frozen image or in presence of significant pleural effusion (i.e. extending over the costophrenic angle). A 4-level congestion score is defined: absence of congestion (0-1 positive points), mild congestion (2-3 positive points), moderate congestion (4-5 positive points) and severe congestion (6-8 positive points).
Procedure: LUS decongestive strategy
Congestion is clinically assessed by calculating the Everest score. This score, previously used in clinical trials, is composed of 3 congestion symptoms (i.e. dyspnea, orthopnoea and fatigue) and 3 congestion signs (i.e. jugular vein distension, lung rales, oedema), each graded from 0 to 3. From the total score, a sub-score is derived, ranging from absence of congestion to severe congestion.
Procedure: PE decongestive strategy
LUS results are documented in the electronic case report form (eCRF) and 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 to step-up, maintain, or step-down the decongestive therapy.
PE results are documented in the eCRF and 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 to step-up, maintain, or step-down the decongestive therapy.
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
Time frame: 40 days from study inclusion
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.
Time frame: 3 working days after randomization
Diuretic dose
Mean daily dose of diuretic therapy during study intervention (in furosemide iv equivalent)
Time frame: 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.
Time frame: Up to 90 days after discharge
Readmission and any-cause mortality
Rate of hospital readmissions and deaths occurring within 90 days of discharge
Time frame: 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
Time frame: Up to 90 days after discharge
Length of hospital stay
Mean length of hospital stay
Time frame: 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.
Time frame: 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.
Time frame: Up to 90 days after discharge
Worsening of renal function
≥50% rise of serum creatinine from baseline value
Time frame: Up to 6 working days after randomisation
Hyponatremia
Rate of severe hyponatremia \<120 mmol/l
Time frame: Up to 6 working days after randomisation
Hypokaliemia
Rate of severe hypokaliemia \<2.5 mmol/l
Time frame: Up to 6 working days after randomisation
Sustained hypotension
proportion of patients needing vasopressor/inotropic agents because of sustained hypotension
Time frame: Up to 6 working days after randomisation
Plan to share: No
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