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.Usual care without ultrasound guidance
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.: 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 without ultrasound guidance: Usual care (i.e. without ultrasound guidance)
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Male or female aged 18 and over
* Heart failure (regardless of left ventricular ejection fraction)
* Diagnosis of heart failure established more than 3 months ago
* Absence of significant clinical signs of congestion on clinical examination (absence of crackles and lower limbs oedema greater than perimalleolar oedema)
* Affiliation to social security
* Receiving complete information about research organization and signed informed consent.
Exclusion Criteria:
* Natriuretic peptides result, carried out during the previous 30 days, available at the inclusion consultation
* Pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis.
* Suspicion of cardiac amyloidosis or proven amyloidosis,
* Patient with severe primary heart valve disease
* Pregnant woman, parturient or nursing mother
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* Person deprived of liberty by a judicial or administrative decision,
* Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Primary outcome measure(s)
Death within 30 days (composite endpoint) — Within 30 days 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).
Hospitalization for heart failure within 30 days (composite endpoint) — Within 30 days 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).
Changes in N-terminal pro b-type natriuretic peptide (NtProBNP) between randomization and D30 (composite endpoint) — Between randomization and Day 30 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).
Trial sites (5)
Facility
City
Region
Status
CHU de Besançon
Besançon
France
Not Yet Recruiting
CH de Mulhouse
Mulhouse
France
Not Yet Recruiting
CHRU de Reims
Reims
France
Not Yet Recruiting
CHR de Metz
Thionville
France
Not Yet Recruiting
CHRU de Nancy
Vandœuvre-lès-Nancy
France
Recruiting
More Central Hospital, Nancy, France trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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