Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
182 participants
INTERVENTIONAL
2023-05-15
2027-06-15
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional group
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.
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.
Control group
Usual care (i.e. without ultrasound guidance) will be provided.
Usual care without ultrasound guidance
Usual care (i.e. without ultrasound guidance)
Interventions
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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.
Usual care without ultrasound guidance
Usual care (i.e. without ultrasound guidance)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Pr. Nicolas GIRERD
MD,PhD
Locations
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CHU de Besançon
Besançon, , France
CH de Mulhouse
Mulhouse, , France
CHRU de Reims
Reims, , France
CHR de Metz
Thionville, , France
CHRU de Nancy
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Marie-France Seronde, MD
Role: primary
David Kenizou, MD
Role: primary
Pierre Nazeyrolas, Md, PhD
Role: primary
Noura Zannad, MD
Role: primary
Other Identifiers
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2019PI094
Identifier Type: -
Identifier Source: org_study_id
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