AMBulatory UltraSound for Heart Failure Management (AMBUSH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / 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.; Procedure: Usual care without ultrasound guidance

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.

• Study Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas GIRERD, MD,PhD; Phone Number: +333 +33 3 83 15 74 96; Email: n.girerd@chru-nancy.fr

Study Locations

• France
  • Besançon, France, 25030
    • Not yet recruiting
    • CHU de Besancon
    • Contact: Marie-France Seronde, MD
    • Principal Investigator: Marie-France Seronde, MD
  • Mulhouse, France, 68070
    • Not yet recruiting
    • CH de Mulhouse
    • Contact: David Kenizou, MD
    • Principal Investigator: David Kenizou, MD
  • Reims, France, 51092
    • Not yet recruiting
    • CHRU de Reims
    • Contact: Pierre Nazeyrolas, Md, PhD
    • Principal Investigator: Pierre Nazeyrolas, MD, PhD
  • Thionville, France, 57126
    • Not yet recruiting
    • CHR de Metz
    • Contact: Noura ZANNAD, MD
    • Principal Investigator: Noura ZANNAD, MD
  • Vandoeuvre Les Nancy, France, 54500
    • Recruiting
    • CHRU de Nancy
    • Contact: Nicolas GIRERD, MD, PhD; Phone Number: +333 +33 3 83 15 74 96; Email: n.girerd@chru-nancy.fr
    • Principal Investigator: Nicolas GIRERD, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; The heart failure treatments will be guided by the results of the lung ultrasound and the evaluation of the inferior vena cava	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.; 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.
Other: Control group; Usual care (i.e. without ultrasound guidance) will be provided.	Procedure: Usual care without ultrasound guidance; Usual care (i.e. without ultrasound guidance)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death within 30 days (composite endpoint)	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).	Within 30 days
Hospitalization for heart failure within 30 days (composite endpoint)	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).	Within 30 days
Changes in N-terminal pro b-type natriuretic peptide (NtProBNP) between randomization and D30 (composite endpoint)	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).	Between randomization and Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	Within the combined outcome of CV death or hospitalization for heart failure. Outcomes will be adjudicated blinded from randomization arm	Within 30 days
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		At baseline in the intervention group and in all patients at Day 30 post inclusion
Circulating levels of natriuretic peptides (NtProBNP)		At baseline and Day 30
Changes in natriuretic peptides (NtProBNP)		Between baseline and Day 30.
Ultrasound congestion defined as in B / and clinical congestion evaluated according to the EVEREST and ASCEND scores		At baseline in the intervention group and in all patients at the Day 30.

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Anticipated): June 15, 2026
• Study Completion (Anticipated): June 15, 2027

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2019PI094

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No