RecruitingNot ApplicableNCT04741711

AMBulatory UltraSound for Heart Failure Management

Impact of Ultrasound-guided Therapeutic Management of Ambulatory Patients With Heart Failure : An Open-label Randomized Clinical Trial

Sponsor

Central Hospital, Nancy, France

Enrollment

182 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria8

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.

Interventions

PROCEDUREAn 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.

PROCEDUREUsual care without ultrasound guidance

Usual care (i.e. without ultrasound guidance)