AMBUSH study is a multicenter randomized, controlled, open-label clinical trial (PROBE (Prospective Randomized Open Blinded End-point) type). The main objective of AMBUSH study is to assess the effect of therapeutic management guided by pulmonary ultrasound and the assessment of the inferior vena cava in patients with heart failure seen in an ambulatory (outpatient) setting on a mixed clinical-biological endpoint (including variations of natriuretic peptides - NtProBNP) at 30 days.
Secondary objectives are: A. To assess the effect of therapeutic management guided by pulmonary ultrasound and inferior vena cava assessment on the risk of cardiovascular death and hospitalization for heart failure at 30 days. B. Describe the proportion of ultrasound congestion (pulmonary and inferior vena cava data) in patients free from clinical congestion at baseline in the intervention group and in all patients at D30 visit. C. Evaluate the association of ultrasound congestion (pulmonary and inferior vena cava assessment) with serum concentrations of natriuretic peptides at baseline and D30 visit. D. Evaluate the association of variations in ultrasound congestion (pulmonary and evaluation of the inferior vena cava) and variations in natriuretic peptides between baseline and D30 visit. E. Compare the proportion of ultrasound and clinical congestion in patients in the intervention group and in the control group at baseline and on D30 visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
An ultrasound (lung and inferior vena cava) will be performed and the heart failure treatments will be guided by the results of the lung ultrasound and the evaluation of the inferior vena cava. The choice of congestion treatment modalities to be implemented is left to the investigators' discretion, in accordance with European practice guidelines.
Usual care (i.e. without ultrasound guidance)
CHU de Besançon
Besançon, France
NOT_YET_RECRUITINGCH de Mulhouse
Mulhouse, France
NOT_YET_RECRUITINGCHRU de Reims
Reims, France
NOT_YET_RECRUITINGCHR de Metz
Death within 30 days (composite endpoint)
The primary endpoint will rank patients from worst to most favourable outcome during the trial. It will be a hierarchical composite of events as described by Felker in 2010 (PMID 20841546).
Time frame: Within 30 days
Hospitalization for heart failure within 30 days (composite endpoint)
The primary endpoint will rank patients from worst to most favourable outcome during the trial. It will be a hierarchical composite of events as described by Felker in 2010 (PMID 20841546).
Time frame: Within 30 days
Changes in N-terminal pro b-type natriuretic peptide (NtProBNP) between randomization and D30 (composite endpoint)
The primary endpoint will rank patients from worst to most favourable outcome during the trial. It will be a hierarchical composite of events as described by Felker in 2010 (PMID 20841546).
Time frame: Between randomization and Day 30
Cardiovascular death
Within the combined outcome of CV death or hospitalization for heart failure. Outcomes will be adjudicated blinded from randomization arm
Time frame: Within 30 days
Ultrasound pulmonary congestion defined ≥3 B-lines on two intercostal spaces bilaterally (8-point method) and systemic congestion defined as an inferior vena cava diameter 21 mm or greater and/or a low variation during the respiratory cycle
Time frame: At baseline in the intervention group and in all patients at Day 30 post inclusion
Circulating levels of natriuretic peptides (NtProBNP)
Time frame: At baseline and Day 30
Changes in natriuretic peptides (NtProBNP)
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Thionville, France
CHRU de Nancy
Vandœuvre-lès-Nancy, France
RECRUITINGTime frame: Between baseline and Day 30.
Ultrasound congestion defined as in B / and clinical congestion evaluated according to the EVEREST and ASCEND scores
Time frame: At baseline in the intervention group and in all patients at the Day 30.