Impact of Ultrasound-guided Therapeutic Management of Ambulatory Patients With Heart Failure : An Open-label Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 10
- 主要终点
- Changes in N-terminal pro b-type natriuretic peptide (NtProBNP) between randomization and D30 (composite endpoint)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in N-terminal pro b-type natriuretic peptide (NtProBNP) between randomization and D30 (composite endpoint)
时间窗: 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).
Death within 30 days (composite endpoint)
时间窗: 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).
Hospitalization for heart failure within 30 days (composite endpoint)
时间窗: 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).
次要结局
- Cardiovascular death(Within 30 days)
- 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.)
- Circulating levels of natriuretic peptides (NtProBNP)(At baseline and Day 30)
- 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)
研究者
Pr. Nicolas GIRERD
MD,PhD
Central Hospital, Nancy, France