AMBulatory UltraSound for Heart Failure Management

NCT04741711 | Recruiting

• 1 other identifier: 2019PI094
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Cardiovascular death

  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.

Study Arms (2)

Interventional group

EXPERIMENTAL

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.

Control group

OTHER

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

Procedure: Usual care without ultrasound guidance

Interventions

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

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.

Interventional group

Usual care without ultrasound guidance PROCEDURE

Usual care (i.e. without ultrasound guidance)

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (5)

CHU de Besançon

Besançon, 25030, France

NOT YET RECRUITING

CH de Mulhouse

Mulhouse, 68070, France

NOT YET RECRUITING

CHRU de Reims

Reims, 51092, France

NOT YET RECRUITING

CHR de Metz

Thionville, 57126, France

NOT YET RECRUITING

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Nicolas GIRERD, MD,PhD

CONTACT

+33 3 83 15 74 96; n.girerd@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 5, 2021
• Study Start: May 15, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

FR (5)