AMBulatory UltraSound for Heart Failure Management (AMBUSH)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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.
Usual care without ultrasound guidance
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- CHU de Besançon
- CH de Mulhouse
- CHRU de Reims
- CHR de Metz
- CHRU de NancyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Interventional group
Control group
Arm Description
The heart failure treatments will be guided by the results of the lung ultrasound and the evaluation of the inferior vena cava
Usual care (i.e. without ultrasound guidance) will be provided.
Outcomes
Primary Outcome Measures
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).
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).
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).
Secondary Outcome Measures
Cardiovascular death
Within the combined outcome of CV death or hospitalization for heart failure. Outcomes will be adjudicated blinded from randomization arm
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
Circulating levels of natriuretic peptides (NtProBNP)
Changes in natriuretic peptides (NtProBNP)
Ultrasound congestion defined as in B / and clinical congestion evaluated according to the EVEREST and ASCEND scores
Full Information
NCT ID
NCT04741711
First Posted
January 29, 2021
Last Updated
May 15, 2023
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT04741711
Brief Title
AMBulatory UltraSound for Heart Failure Management
Acronym
AMBUSH
Official Title
Impact of Ultrasound-guided Therapeutic Management of Ambulatory Patients With Heart Failure : An Open-label Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
June 15, 2026 (Anticipated)
Study Completion Date
June 15, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
The heart failure treatments will be guided by the results of the lung ultrasound and the evaluation of the inferior vena cava
Arm Title
Control group
Arm Type
Other
Arm Description
Usual care (i.e. without ultrasound guidance) will be provided.
Intervention Type
Procedure
Intervention Name(s)
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.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Usual care without ultrasound guidance
Intervention Description
Usual care (i.e. without ultrasound guidance)
Primary Outcome Measure Information:
Title
Death within 30 days (composite endpoint)
Description
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).
Time Frame
Within 30 days
Title
Hospitalization for heart failure within 30 days (composite endpoint)
Description
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).
Time Frame
Within 30 days
Title
Changes in N-terminal pro b-type natriuretic peptide (NtProBNP) between randomization and D30 (composite endpoint)
Description
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).
Time Frame
Between randomization and Day 30
Secondary Outcome Measure Information:
Title
Cardiovascular death
Description
Within the combined outcome of CV death or hospitalization for heart failure. Outcomes will be adjudicated blinded from randomization arm
Time Frame
Within 30 days
Title
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
Title
Circulating levels of natriuretic peptides (NtProBNP)
Time Frame
At baseline and Day 30
Title
Changes in natriuretic peptides (NtProBNP)
Time Frame
Between baseline and Day 30.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas GIRERD, MD,PhD
Phone
+33 3 83 15 74 96
Ext
+333
Email
n.girerd@chru-nancy.fr
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-France Seronde, MD
First Name & Middle Initial & Last Name & Degree
Marie-France Seronde, MD
Facility Name
CH de Mulhouse
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kenizou, MD
First Name & Middle Initial & Last Name & Degree
David Kenizou, MD
Facility Name
CHRU de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Nazeyrolas, Md, PhD
First Name & Middle Initial & Last Name & Degree
Pierre Nazeyrolas, MD, PhD
Facility Name
CHR de Metz
City
Thionville
ZIP/Postal Code
57126
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noura Zannad, MD
First Name & Middle Initial & Last Name & Degree
Noura Zannad, MD
Facility Name
CHRU de Nancy
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas GIRERD, MD, PhD
Phone
+33 3 83 15 74 96
Ext
+333
Email
n.girerd@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Nicolas GIRERD, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
AMBulatory UltraSound for Heart Failure Management
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