Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique à Fraction d'éjection préservée. CHF-COV Preserved (Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Rate of day-hospital or in-home IV diuretics injection for acute HF
研究概览
简要总结
Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.
The main objective of the CHF-COV Preserved study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with preserved left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.
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 with chronic acute heart failure with preserved ejection fraction admitted in hospital for scheduled day hospitalization or consultation
- •Patient with preserved left ventricular ejection fraction (≥50%).
- •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 day-hospital or in-home IV diuretics injection for acute HF
时间窗: 24 months after inclusion
composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following inclusion (with outcome 1 and 2)
Rate of death from all causes
时间窗: 24 months after inclusion
composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following inclusion (with outcome 2 and 3)
Rate of hospitalisation for acute heart failure
时间窗: 24 months after inclusion
composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following inclusion (with outcome 1 and 3)
次要结局
- Number of B-lines measured in lung echography(At baseline)
- Rate of bilirubin(At baseline)
- Rate of ASAT(At baseline)
- Renal function(At baseline)
- Plasma volume(At baseline)
- Rate of hospitalisation for cardiovascular reason(24 months after inclusion)
- Rate of cardiovascular death(24 months after inclusion)
- NYHA (New York Heart Association) class measured(3, 12 and 24 months after inclusion)
- Natriuretic peptides(At baseline)
- Blood potassium concentration(At baseline)
- Rate of day-hospital or in-home IV diuretics injection for acute HF(24 months after inclusion)
- Rate of V factor(At baseline)
- Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)(At inclusion and 3, 6 and 24 months)
- Rate of ALAT(At baseline)
- Liver elastography value(At inclusion)
- Rate of hospitalisation for acute heart failure(24 months after inclusion)
- Rate of death from all causes(24 months after inclusion)
研究者
Pr. Nicolas GIRERD
Principal Investigator
Central Hospital, Nancy, France