Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography
ConditionAcute Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntonio Leidi
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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).
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
LUS decongestive strategy
Procedure/SurgeryLUS 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 strategy
Procedure/SurgeryPE 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.
Treatment groups
222 Participants
are divided into 2 treatment groupsGroup A: Lung ultrasonography (LUS)Experimental treatment 1 intervention
Group B: Physical Examination (PE)Active comparator 1 intervention
Trial outcomes
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
Time frame
40 days from study inclusionSecondary outcomes
1
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 randomization2
Diuretic dose
Mean daily dose of diuretic therapy during study intervention (in furosemide iv equivalent)
Time frame
Uo to 6 working days after randomisation3
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 discharge4
Readmission and any-cause mortality
Rate of hospital readmissions and deaths occurring within 90 days of discharge
Time frame
Up to 90 days after dischargeOther outcomes
1
Worsening of renal function
≥50% rise of serum creatinine from baseline value
Time frame
Up to 6 working days after randomisation2
Hyponatremia
Rate of severe hyponatremia \<120 mmol/l
Time frame
Up to 6 working days after randomisation3
Hypokaliemia
Rate of severe hypokaliemia \<2.5 mmol/l
Time frame
Up to 6 working days after randomisation4
Sustained hypotension
proportion of patients needing vasopressor/inotropic agents because of sustained hypotension
Time frame
Up to 6 working days after randomisationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Antonio Leidi
Lead sponsor
University Hospital, Geneva
Sponsor institution
University Hospital, Geneva
Collaborator
Source ClinicalTrials.gov