AMBulatory UltraSound for Heart Failure Management (AMBUSH)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Heart Failure

Treatments: Procedure: Usual care without ultrasound guidance; Procedure: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT04741711

2019PI094

Details and patient eligibility

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.

Full description

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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Interventional group

Experimental group

Description:

The heart failure treatments will be guided by the results of the lung ultrasound and the evaluation of the inferior vena cava

Treatment:

Procedure: 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.

Control group

Other group

Description:

Usual care (i.e. without ultrasound guidance) will be provided.

Treatment:

Procedure: Usual care without ultrasound guidance