Investigating ACute HeArt FailuRe Decongestion Guided by Lung UltraSonography

NCT ID: NCT06465498

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-22
• Study Completion Date: 2026-08-30

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.

Conditions

Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lung ultrasonography (LUS)

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).

Group Type: EXPERIMENTAL

LUS decongestive strategy

Intervention Type: PROCEDURE

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.

Physical Examination (PE)

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.

Group Type: ACTIVE_COMPARATOR

PE decongestive strategy

Intervention Type: PROCEDURE

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.

Interventions

LUS 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.

Intervention Type: PROCEDURE

PE 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.

Intervention Type: PROCEDURE

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).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Antonio Leidi

OTHER

Sponsor Role: lead

Responsible Party

Antonio Leidi

M.D., Principal Investigator, Attending physician in Internal and Emergency Medicine Services

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland

Site Status: RECRUITING

Inselspital, Universitätspital

Bern, Switzerland, Switzerland

Site Status: RECRUITING

Fribourg University Hospital

Fribourg, , Switzerland

Site Status: RECRUITING

Ospedale Civico, Ente Ospedaliero Cantonale

Lugano, , Switzerland

Site Status: NOT_YET_RECRUITING

Countries

Switzerland

Facility Contacts

Antonio Leidi, MD

Role: primary

Antonio.Leidi@hug.ch

+41223729101

Claudio Schneider

Role: primary

claudio.schneider@insel.ch

+41 31 632 21 11

Fernando Esposito

Role: primary

Fernando.Esposito@hfr.ch

+41 26 306 23 64

Michele Bedulli

Role: primary

Michele.Bedulli@eoc.ch

+41 91 811 76 81

Other Identifiers

2024-00268

Identifier Type: -

Identifier Source: org_study_id