Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography

Antonio Leidi222 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Acute Heart Failure

Interventions

LUS decongestive strategyPROCEDURE

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 decongestive strategyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Trois-Chêne Hospital, Geneva Univesity Hospitals

Geneva, Canton of Geneva, Switzerland

RECRUITING

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland

RECRUITING

Inselspital, Universitätspital

Bern, Switzerland, Switzerland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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