Acute Heart Failure
Conditions
Keywords
Lung ultrasonography, Ultrasound, Point-of-care ultrasonography, Decongestion, Diuretic
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.
Interventions
PROCEDURELUS 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.
PROCEDUREPE decongestive strategy
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.
Sponsors
Antonio Leidi
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
To reduce the risk of bias several levels of blinding are introduced: 1. Patients are blinded to their study arm allocation. 2. Treating physicians are blinded to the patient's study arm (both PE and POCUS arms will benefit from recommendations for decongestive therapy based on a generic congestion score). 3. Both sonographers and clinical investigators are reciprocally blinded and masked to the patient's study arm and clinical data files. 4. Outcomes adjudicators are blinded the patient's study arm 5. The biostatistician is blinded to the patients' study arm
Intervention model description
Multicentric blinded randomized controlled trial (RCT)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Diuretic dose | Uo to 6 working days after randomisation | Mean daily dose of diuretic therapy during study intervention (in furosemide iv equivalent) |
| 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. |
| 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. |
| 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. |
Countries
Switzerland
Outcome results
None listed