Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique. CHF-COV (Chronic Heart Failure - COngestion eValuation)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure
- Sponsor
- Pr. Nicolas GIRERD
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Rate of death from all causes
- 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 study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF that are associated with the risk of all-cause death or hospitalization for acute HF within 24 months after day hospitalization.
Investigators
Pr. Nicolas GIRERD
Principal Investigator
Central Hospital, Nancy, France
Eligibility Criteria
Inclusion Criteria
- •Patients with chronic acute heart failure admitted in hospital for scheduled day hospitalization or consultation
- •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 or hospitalisation for acute heart failure during 24 months following day hospitalization (with outcome 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 or hospitalisation for acute heart failure during 24 months following day hospitalization (with outcome 1)
Secondary Outcomes
- Rate of ALAT(At inclusion)
- Rate of ASAT(At inclusion)
- Rate of Bilirubin(At inclusion)
- Renal function assessed by glomerular filtration rate(At inclusion)
- Plasma volume(At inclusion)
- Rate of death from all causes(24 months after day hospitalization or consultation)
- Rate of hospitalisation for acute heart failure(24 months after day hospitalization or consultation)
- Rate of hospitalisation for cardiovascular reason(24 months after day hospitalization or consultation)
- Rate of cardiovascular death(24 months after day hospitalization or consultation)
- NYHA (New York Heart Association) class measured(3, 12 and 24 months after day hospitalization or consulation)
- Natriuretic peptides(At inclusion)
- Rate of V factor(At inclusion)
- Blood potassium concentration(At inclusion)
- Liver elastography value(At inclusion)
- Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)(At inclusion and 3, 6 and 24 months)