Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection préservée
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Rate of all-cause death
研究概览
简要总结
The AHF-CODE preserved study is a prospective, non-randomized, monocenter study performed in patients with heart failure with preserved ejection fraction admitted for worsening heart failure.
The main objective of the AHF-CODE preserved study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.
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.
- •Patient with preserved ejection fraction (FE ≥ 50%).
- •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 or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2 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 or re-hospitalisation for acute heart failure at 3 months after hospital discharge (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 or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 1 and 3)
次要结局
- NYHA (New York Heart Association) class(3, 12 and 24 months after hospital discharge)
- Rate of re-hospitalisation for acute heart failure(3, 12 and 24 months after hospital discharge)
- Natriuretic peptides(At inclusion)
- Renal function assessed by glomerular filtration rate(At inclusion)
- Plasma volume(At inclusion)
- Liver elastography value(At inclusion)
- Quality of life assessed by Kansas City Cardiomyopathy Questionnaire(At inclusion and 3, 6 and 24 months)
- rate of day-hospital or in home IV diuretics injection for acute HF(3, 12 and 24 months after hospital discharge)
- Blood potassium(At inclusion)
- Rate of death from all causes(3, 12 and 24 months after hospital discharge)
- Rate of all-cause death(3, 12 and 24 months after hospital discharge)
- Rate of hospitalisation for acute heart failure(3, 12 and 24 months after hospital discharge)
研究者
Pr. Nicolas GIRERD
Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection préservée
Central Hospital, Nancy, France