Evaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection altérée ou modérément altérée CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Rate of death from all causes
Study Overview
Brief Summary
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-COVReduced study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with reduced 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization or in consultation
- •Patient with altered (left ventricular ejection fraction <40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Rate of death from all causes
Time Frame: 24 months after day hospitalization or consultation
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 day hospitalization (with outcome 2 and 3)
Rate of day-hospital or in-home IV diuretics injection for acute HF
Time Frame: 24 months after day hospitalization or consultation
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 day hospitalization (with outcome 1 and 2)
Rate of hospitalisation for acute heart failure
Time Frame: 24 months after day hospitalization or consultation
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 day hospitalization (with outcome 1 and 3)
Secondary Outcomes
- Circulating NtProBNP(At inclusion)
- Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)(At inclusion and 3, 6 and 24 months)
- Rate of ASAT(At inclusion)
- Liver elastography value(At inclusion)
- Rate of hospitalisation for cardiovascular reason(24 months after day hospitalization or consultation)
- Rate of cardiovascular death(24 months after day hospitalization or consultation)
- Natriuretic peptides(At inclusion)
- Renal function(At inclusion)
- Plasma volume(At inclusion)
- Rate of V factor(At inclusion)
- Rate of day-hospital or in-home IV diuretics injection for acute HF(24 months after day hospitalization or consultation)
- Rate of ALAT(At inclusion)
- Blood potassium concentration(At inclusion)
- Rate of death from all causes(3, 12 and 24 months after day hospitalization or consulation)
- NYHA (New York Heart Association) class measured(3, 12 and 24 months after day hospitalization or consultation)
- Rate of Bilirubin(At inclusion)
- Rate of hospitalisation for acute heart failure(24 months after day hospitalization or consultation)
Investigators
Pr. Nicolas GIRERD
Principal Investigator
Central Hospital, Nancy, France