Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography

NCT06465498 | Recruiting DMC

• 1 other identifier: 2024-00268
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 5

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).

Conditions

Acute Heart Failure

Keywords

Lung ultrasonography; Ultrasound; Point-of-care ultrasonography; Decongestion; Diuretic

Outcome Measures

Primary Outcomes (1)

• 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

  40 days from study inclusion

Secondary Outcomes (8)

• Successful decongestion

  3 working days after randomization

• Diuretic dose

  Uo to 6 working days after randomisation

• EQ-5D-5L questionary

  Up to 90 days after discharge

• Readmission and any-cause mortality

  Up to 90 days after discharge

• HF-related hospitalisation

  Up to 90 days after discharge

Other Outcomes (4)

• Worsening of renal function

  Up to 6 working days after randomisation

• Hyponatremia

  Up to 6 working days after randomisation

• Hypokaliemia

  Up to 6 working days after randomisation

Study Arms (2)

Lung ultrasonography (LUS)

EXPERIMENTAL

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

Physical Examination (PE)

ACTIVE COMPARATOR

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

Interventions

LUS decongestive strategy 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.

Lung ultrasonography (LUS)

PE decongestive strategy 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.

Physical Examination (PE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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).

You may not qualify if:

• Known isolated right heart failure
• 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

Sponsors & Collaborators

• Antonio Leidi: lead
• University Hospital, Geneva: collaborator

Study Sites (5)

Trois-Chêne Hospital, Geneva Univesity Hospitals

Geneva, Canton of Geneva, 1204, Switzerland

RECRUITING

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

Inselspital, Universitätspital

Bern, Switzerland, Switzerland

RECRUITING

Fribourg University Hospital

Fribourg, Switzerland

RECRUITING

Ospedale Civico, Ente Ospedaliero Cantonale

Lugano, Switzerland

TERMINATED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Principal Investigator, Attending physician in Internal and Emergency Medicine Services

Model Details: Multicentric blinded randomized controlled trial (RCT)

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5)