Acute Heart Failure - COngestion Discharge Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.

Conditions
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Acute Heart Failure

Intervention / Treatment
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* Procedure: Clinical examination centered on congestion
* Procedure: Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography
* Procedure: Blood sample retrieved for biological assessment and biobanking
* Procedure: Telephone follow-up
* Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients hospitalized for acute heart failure<br>Patients hospitalized for acute heart failure will undergo the following evaluations: Clinical examination focusing on congestion Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds Blood sample retrieved for biological assessment and biobanking Telephone follow-up | Procedure: Clinical examination centered on congestion<br>* Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital<br>Procedure: Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography<br>* Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital<br>Procedure: Blood sample retrieved for biological assessment and biobanking<br>* Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital<br>Procedure: Telephone follow-up<br>* Telephone follow-up will be performed 3, 12 and 24 months after discharge from hospital<br>Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)<br>* Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause death | 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) | 3 months after hospital discharge | 
| Rate of re-hospitalisation for acute heart failure | 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) | 3 months after hospital discharge | 
| Rate of day-hospital or in-home IV diuretics injection for acute HF | 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) | 3 months after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause death |  | 3, 12 and 24 months after hospital discharge | 
| Rate of re-hospitalisation for acute heart failure |  | 3,12 and 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 all-cause death | composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 8 and 9) | 12 and 24 months after hospital discharge | 
| Rate of re-hospitalisation for acute heart failure | composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 7 and 9) | 12 and 24 months after hospital discharge | 
| Rate of day-hospital or in-home IV diuretics injection for acute HF | composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF at 12 and 24 months following hospitalization (with outcome 7 and 8) | 12 and 24 months after hospital discharge. | 
| Rate of all-cause death | 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 11 and 12) | 3, 12 and 24 months after hospital discharge. | 
| Rate of hospitalization for acute heart failure | 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 10 and 12) | 3, 12 and 24 months after hospital discharge. | 
| Rate of day-hospital or in-home IV diuretics injection for acute HF | 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 10 and 11) | 3, 12 and 24 months after hospital discharge. | 
| NYHA (New York Heart Association) class measured |  | 3, 12 and 24 months after hospital discharge | 
| Natriuretic peptides | BNP or Nt-Pro BNP | within 24 months after hospital discharge. | 
| Renal function assessed by glomerular filtration rate |  | within 24 months after hospital discharge. | 
| Plasma volume | calculated from haemoglobin and haematocrit value | within 24 months after hospital discharge. | 
| Liver elastography value | Measured with Fibroscan | At inclusion | 
| Quality of life | Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | At inclusion and 3, 6 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Heart Failure