Status:
RECRUITING
AMBulatory UltraSound for Heart Failure Management
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 effec...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2027
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04741711
Start Date
May 15 2023
End Date
June 15 2027
Last Update
May 17 2023
Active Locations (5)
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1
CHU de Besançon
Besançon, France, 25030
2
CH de Mulhouse
Mulhouse, France, 68070
3
CHRU de Reims
Reims, France, 51092
4
CHR de Metz
Thionville, France, 57126