Clinical trial NCT04741711: AMBulatory UltraSound for Heart Failure Management
Official title: Impact of Ultrasound-guided Therapeutic Management of Ambulatory Patients With Heart Failure : An Open-label Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Death within 30 days (composite endpoint)
timeFrame: Within 30 days
measure: Hospitalization for heart failure within 30 days (composite endpoint)
timeFrame: Within 30 days
measure: Changes in N-terminal pro b-type natriuretic peptide (NtProBNP) between randomization and D30 (composite endpoint)
timeFrame: Between randomization and Day 30
Secondary outcomes:
measure: Cardiovascular death
timeFrame: Within 30 days
measure: 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
timeFrame: At baseline in the intervention group and in all patients at Day 30 post inclusion
measure: Circulating levels of natriuretic peptides (NtProBNP)
timeFrame: At baseline and Day 30
measure: Changes in natriuretic peptides (NtProBNP)
timeFrame: Between baseline and Day 30.
measure: Ultrasound congestion defined as in B / and clinical congestion evaluated according to the EVEREST and ASCEND scores
timeFrame: At baseline in the intervention group and in all patients at the Day 30.
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Mulhouse
country: France
facility: CH de Mulhouse
city: Reims
country: France
facility: CHRU de Reims
city: Thionville
country: France
facility: CHR de Metz
city: Vandoeuvre Les Nancy
country: France
facility: CHRU de Nancy
Study officials:
References: