Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d'Une Hospitalisation Pour Insuffisance Cardiaque aigüe
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Rate of day-hospital or at-home IV diuretics injection for acute HF
研究概览
简要总结
The AHF-CORE study is a prospective, non-randomized, multicenter regional study.
The main objective of the AHF-CORE study is to identify congestion markers (clinical, biological and ultrasound) at the beginning and at the end of hospitalization for acute heart failure that are more strongly associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.
Secondary objectives are:
- Quantify the variations in congestion markers between the beginning and end of hospitalization for acute heart failure.
- Assess the correlation between changes in congestion markers between the beginning and end of hospitalization.
- Identify the congestion markers at the beginning of hospitalization that are most strongly associated with residual congestion at the end of hospitalization.
- Identify the added value of ultrasound and biological markers of congestion in addition to clinical variables for the prediction of all-cause death or hospitalization for acute heart failure at 3 months after hospital discharge.
- Identify the association of ultrasound and biologic congestion markers assessed at admission and final discharge with NYHA class at 3 months after hospital discharge
详细描述
Congestion (clinical, biological and ultrasound evaluation) will be quantified at inclusion within 72 hours of admission and before hospital discharge.
Follow-up at 3 months of hospital discharge will be performed through telephone interviews. Vital status and rehospitalization status will be collected.
Throughout the study, patients will continue to be treated according to usual routine care, regardless of their level of congestion. There will be no modification of treatment according to the congestion data acquired within the setting of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 hospitalized for left-sided or global acute heart failure due to exacerbation of chronic heart failure within 72 hours of admission to hospital
- •Patients over 18 years old
- •Person affiliated to or beneficiary of a social security plan
- •Person informed about study organization and having signed the informed consent
排除标准
- •Comorbidity for which life expectancy is ≤ 3 months
- •Diagnosis of heart failure made less than 3 months prior to inclusion
- •Exacerbation of heart failure attributed to acute ischemic stroke (acute coronary syndrome with or without ST segment elevation)
- •Dialyzed patient (peritoneal dialysis or hemodialysis) and patients with glomerular filtration rate <15 ml / min / m2 at baseline
- •History of pulmonary lobectomy or pneumonectomy
- •Severe pulmonary or pleural disease preventing the reliable acquisition of pulmonary ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis
- •Suspected cardiac amylose or proven cardiac amylose
- •Woman of childbearing age without effective contraception
- •Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the French Public Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of public guardianship) ; Adult person incapable of giving consent and not under legal protection.
- •Persons deprived of liberty for judicial or administrative decision
- •Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code
结局指标
主要结局
Rate of day-hospital or at-home IV diuretics injection for acute HF
时间窗: at 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 the day hospitalization (with outcome 1 and 2)
Rate of all-cause death
时间窗: at 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 the day hospitalization (with outcome 2 and 3)
Rate of rehospitalization for acute heart failure
时间窗: at 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 the day hospitalization (with outcome 1 and 3)
次要结局
- NYHA class(3 months after hospital discharge)
- Ultrasound congestion markers(at admission and at final discharge (an average of 10 days after admission))
- Rate of all-cause death(12 and 24 months after hospitalization)
- Rate of day-hospital or in-home IV diuretics injection for acute HF(12 and 24 months after hospitalization)
- Clinical congestion markers as assessed with the Ambrosy Score(at admission and at final discharge (an average of 10 days after admission))
- Clinical congestion markers as assessed with the ASCEND score(at admission and at final discharge (an average of 10 days after admission))
- Natriuretic peptides(at admission and at final discharge (an average of 10 days after admission))
- Estimated plasma volume(at admission and at final discharge (an average of 10 days after admission))
- Residual congestion(at final discharge (an average of 10 days after admission))
- Rate of hospitalization for acute heart failure(12 and 24 months after hospitalization)
- Rate of day-hospital for Intravenous diuretics administration for acute HF(3, 12 and 24 months after hospitalization)
研究者
Pr. Nicolas GIRERD
Professor
Central Hospital, Nancy, France