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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic HFpEF coming for scheduled day hospitalization or consultation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical examination centered on congestion | Procedure | Clinical examination centered on congestion (including the EVEREST, Ambrosy and ASCEND score) 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 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas GIRERD, MD, PhD | Contact | + 33 3 83 15 73 22 | + 33 3 | n.girerd@chru-nancy.fr |
| Sanae BOUALI | Contact | + 33 3 83 15 73 22 | + 33 3 | s.bouali@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 and liver elastography | Procedure | 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 |
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| Blood and urine sample retrieved for biological assessment and biobanking | Procedure | 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 |
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| Telephone follow-up | Other | Telephone follow-up will be performed 3, 12 and 24 |
|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Behavioral | Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge |
|
| 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 |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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