Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography
- Conditions
- Acute Heart Failure
- Interventions
- Procedure: LUS decongestive strategyProcedure: PE decongestive strategy
- Registration Number
- NCT06465498
- Lead Sponsor
- Antonio Leidi
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 222
- ≥ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lung ultrasonography (LUS) LUS decongestive strategy 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). Physical Examination (PE) PE 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.
- Primary Outcome Measures
Name Time Method DAOH-40 40 days from study inclusion 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
- Secondary Outcome Measures
Name Time Method Diuretic dose Uo to 6 working days after randomisation Mean daily dose of diuretic therapy during study intervention (in furosemide iv equivalent)
Anxiety and depression Up to 90 days after discharge Hospital Anxiety and Depression Scale, two subscales ranging from 0 to 21 points, higher scores mean worse outcome.
EQ-5D-5L questionary Up to 90 days after discharge 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.
Successful decongestion 3 working days after randomization 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.
Readmission and any-cause mortality Up to 90 days after discharge Rate of hospital readmissions and deaths occurring within 90 days of discharge
HF-related hospitalisation Up to 90 days after discharge Rate of HF-related hospitalisation, as defined by the presence of worsening signs and symptoms of HF and an intensification of the diuretic therapy
Length of hospital stay Through hospitalization, an average of 9 days Mean length of hospital stay
Dyspnea Up to 90 days after discharge Dyspnea assessed with a 100-mm Visual Analog Scale (VAS), score ranging from 0 to 100, higher scores mean worse outcome.
Trial Locations
- Locations (4)
Inselspital, Universitätspital
🇨🇭Bern, Switzerland
Fribourg University Hospital
🇨🇭Fribourg, Switzerland
Ospedale Civico, Ente Ospedaliero Cantonale
🇨🇭Lugano, Switzerland
Geneva University Hospitals
🇨🇭Geneva, Switzerland