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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-COVReduced study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with reduced 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical examination centered on congestion | Procedure | Clinical examination centered on congestion (including the EVEREST, ASCEND and Ambrosy scores) will be performed during day hospitalization or consultation |
| 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 day hospitalization (with outcome 2 and 3) | 24 months after day hospitalization or consultation |
| 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 day hospitalization (with outcome 1 and 3) | 24 months after day hospitalization or consultation |
| 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 day hospitalization (with outcome 1 and 2) | 24 months after day hospitalization or consultation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of death from all causes | composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 5) | 24 months after day hospitalization or consultation |
| Rate of hospitalisation for acute heart failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas GIRERD, MD, PhD | Contact | 0033383157322 | +33 | n.girerd@chru-nancy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nancy | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
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| Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds | Procedure | Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds are optional |
|
| Blood sample retrieved for biological assessment and biobanking | Procedure | Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation |
|
| Telephone follow-up | Other | Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization or consultation |
|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Behavioral | Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge |
|
composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 4) |
| 24 months after day hospitalization or consultation |
| Rate of death from all causes | 24 months after day hospitalization or consultation |
| 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 day hospitalization (with outcome 8) | 24 months after day hospitalization or consultation |
| 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 day hospitalization (with outcome 7) | 24 months after day hospitalization or consultation |
| Rate of hospitalisation for cardiovascular reason | 24 months after day hospitalization or consultation |
| Rate of death from all causes | composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 11) | 3, 12 and 24 months after day hospitalization or consulation |
| 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 day hospitalization (with outcome 10) | 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 consultation |
| Natriuretic peptides | BNP or Nt-Pro BNP | At inclusion |
| Renal function | Assessed by glomerular filtration rate | At inclusion |
| Plasma volume | calculated from haemoglobin and haematocrit value | At inclusion |
| Rate of Bilirubin | At inclusion |
| Rate of ASAT | At inclusion |
| Rate of ALAT | At inclusion |
| Rate of V factor | At inclusion |
| Blood potassium concentration | At inclusion |
| Circulating NtProBNP | At inclusion |
| 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 |