Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Chronic Heart Failure, Preserved Ejection Fraction

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


Participation Criteria
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Eligibility Criteria
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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.

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 with chronic HFpEF coming for scheduled day hospitalization or consultation<br>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 (including the EVEREST, Ambrosy and ASCEND score) will be performed during day hospitalization or consultation<br>Procedure: Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography<br>* Cardiac, vena cava, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds and liver elastography are optional/Cardiac echo is optional for patients included in consultation<br>Procedure: Blood and urine sample retrieved for biological assessment and biobanking<br>* Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation/ Urine analysis is optional for patients included in consultation<br>Other: Telephone follow-up<br>* Telephone follow-up will be performed 3, 12 and 24<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 death from all causes | 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) | 24 months after inclusion | 
| Rate of hospitalisation for acute heart failure | 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) | 24 months after inclusion | 
| Rate of day-hospital or in-home IV diuretics injection for acute HF | 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) | 24 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of B-lines measured in lung echography |  | At baseline | 
| Rate of death from all causes | composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 6) | 24 months after inclusion | 
| Rate of hospitalisation for acute heart failure | composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 5) | 24 months after inclusion | 
| Rate of death from all causes |  | 24 months after inclusion | 
| Rate of hospitalisation for acute heart failure | composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after inclusion (with outcome 9) | 24 months after day hospitalization | 
| Rate of day-hospital or in-home IV diuretics injection for acute HF | composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after inclusion (with outcome 8) | 24 months after inclusion | 
| Rate of hospitalisation for cardiovascular reason |  | 24 months after inclusion | 
| Rate of death from all causes | composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 12) | 24 months after inclusion | 
| Rate of hospitalisation for acute heart failure | composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 11) | 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 | BNP or Nt-Pro BNP | At baseline | 
| Renal function | Assessed by glomerular filtration rate | At baseline | 
| Plasma volume | Calculated from haemoglobin and haematocrit value | At baseline | 
| Rate of bilirubin |  | At baseline | 
| Rate of ASAT |  | At baseline | 
| Rate of ALAT |  | At baseline | 
| Rate of V factor |  | At baseline | 
| Blood potassium concentration |  | At baseline | 
| 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 |