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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Rate of day-hospital or in-home IV diuretics injection for acute HF
- Status
- Recruiting
- Last Updated
- 2 years ago
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-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.
Investigators
Pr. Nicolas GIRERD
Principal Investigator
Central Hospital, Nancy, France
Eligibility Criteria
Inclusion Criteria
- •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
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 day-hospital or in-home IV diuretics injection for acute HF
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Secondary Outcomes
- 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 death from all causes(24 months after inclusion)
- 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 hospitalisation for acute heart failure(24 months after inclusion)
- Rate of ALAT(At baseline)
- Liver elastography value(At inclusion)