AMBulatory UltraSound for Heart Failure Management
Recruiting · NCT04741711 · Interventional (participants receive a specific treatment) · Lead sponsor: Central Hospital, Nancy, France
View the official record on ClinicalTrials.gov →Interventions studied
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
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
5 locations listed.
- CHU de Besançon - Besançon, France
- CH de Mulhouse - Mulhouse, France
- CHRU de Reims - Reims, France
- CHR de Metz - Thionville, France
- CHRU de Nancy - Vandœuvre-lès-Nancy, France