Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Rate of all-cause death
研究概览
简要总结
Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by cardiac and pulmonary ultrasound .
Adapting treatment according to lung congestion assessed by implantable devices (not reimbursed in France) improves the prognosis. However, due to the lack of a standardised congestion assessment, therapeutic adaptation in acute heart failure is currently empirical. The best multimodality approach to congestion evaluation is uncertain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients hospitalised for acute heart failure.
- •Patients considered clinically discharging from hospitalisation for acute heart failure.
- •Age ≥18 years
- •Patients having received complete information regarding the study design and having signed their informed consent form.
- •Patient affiliated to or beneficiary of a social security scheme.
排除标准
- •Comorbidity for which the life expectancy is ≤ 3 months
- •Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate <15 ml/min/m2 at inclusion.
- •History of lobectomy or pneumonectomy lung surgery
- •Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
- •Pregnant woman, parturient or nursing mother
- •Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- •Adult person who is unable to give consent
- •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
Rate of all-cause death
时间窗: 3 months after hospital discharge
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 2 and 3)
Rate of re-hospitalisation for acute heart failure
时间窗: 3 months after hospital discharge
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 3)
Rate of day-hospital or in-home IV diuretics injection for acute HF
时间窗: 3 months after hospital discharge
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 2)
次要结局
- Rate of all-cause death(3, 12 and 24 months after hospital discharge.)
- NYHA (New York Heart Association) class measured(3, 12 and 24 months after hospital discharge)
- Liver elastography value(At inclusion)
- Renal function assessed by glomerular filtration rate(within 24 months after hospital discharge.)
- Rate of day-hospital or in-home IV diuretics injection for acute HF(3, 12 and 24 months after hospital discharge.)
- Rate of hospitalization for acute heart failure(3, 12 and 24 months after hospital discharge.)
- Plasma volume(within 24 months after hospital discharge.)
- Rate of re-hospitalisation for acute heart failure(12 and 24 months after hospital discharge)
- Natriuretic peptides(within 24 months after hospital discharge.)
- Quality of life(At inclusion and 3, 6 and 24 months)
研究者
Pr. Nicolas GIRERD
Principal Investigator
Central Hospital, Nancy, France