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NCT Number: NCT04741711

AMBulatory UltraSound for Heart Failure Management

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon, Besançon, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Usual care without ultrasound guidance

Procedure

Usual care (i.e. without ultrasound guidance)

Primary outcomes

  1. Death within 30 days (composite endpoint)

    Time frame: Within 30 days

    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).

  2. Hospitalization for heart failure within 30 days (composite endpoint)

    Time frame: Within 30 days

    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).

  3. Changes in N-terminal pro b-type natriuretic peptide (NtProBNP) between randomization and D30 (composite endpoint)

    Time frame: Between randomization and Day 30

    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).

Secondary outcomes

  1. Cardiovascular death

    Time frame: Within 30 days

    Within the combined outcome of CV death or hospitalization for heart failure. Outcomes will be adjudicated blinded from randomization arm

  2. 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

    Time frame: At baseline in the intervention group and in all patients at Day 30 post inclusion

  3. Circulating levels of natriuretic peptides (NtProBNP)

    Time frame: At baseline and Day 30

  4. Changes in natriuretic peptides (NtProBNP)

    Time frame: Between baseline and Day 30.

  5. Ultrasound congestion defined as in B / and clinical congestion evaluated according to the EVEREST and ASCEND scores

    Time frame: At baseline in the intervention group and in all patients at the Day 30.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas GIRERD, MD,PhD

CONTACT

[email protected]

+33 3 83 15 74 96 ext. +333

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: AMBUSH

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 5, 2021
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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