Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Heart Failure
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Rate of all-cause death
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by cardiac and pulmonary ultrasound .
Adapting treatment according to lung congestion assessed by implantable devices (not reimbursed in France) improves the prognosis. However, due to the lack of a standardised congestion assessment, therapeutic adaptation in acute heart failure is currently empirical. The best multimodality approach to congestion evaluation is uncertain.
Investigators
Pr. Nicolas GIRERD
Principal Investigator
Central Hospital, Nancy, France
Eligibility Criteria
Inclusion Criteria
- •Patients hospitalised for acute heart failure.
- •Patients considered clinically discharging from hospitalisation for acute heart failure.
- •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 all-cause death
Time Frame: 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 day hospitalization (with outcome 2 and 3)
Rate of re-hospitalisation for acute heart failure
Time Frame: 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 day hospitalization (with outcome 1 and 3)
Rate of day-hospital or in-home IV diuretics injection for acute HF
Time Frame: 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 day hospitalization (with outcome 1 and 2)
Secondary Outcomes
- Rate of all-cause death(3, 12 and 24 months after hospital discharge.)
- NYHA (New York Heart Association) class measured(3, 12 and 24 months after hospital discharge)
- Liver elastography value(At inclusion)
- Renal function assessed by glomerular filtration rate(within 24 months after hospital discharge.)
- Rate of day-hospital or in-home IV diuretics injection for acute HF(3, 12 and 24 months after hospital discharge.)
- Rate of hospitalization for acute heart failure(3, 12 and 24 months after hospital discharge.)
- Plasma volume(within 24 months after hospital discharge.)
- Rate of re-hospitalisation for acute heart failure(12 and 24 months after hospital discharge)
- Natriuretic peptides(within 24 months after hospital discharge.)
- Quality of life(At inclusion and 3, 6 and 24 months)