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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Clinical examination centered on congestion (including the EVEREST, Ambrosy and ASCEND score) will be performed during day hospitalization or consultation
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
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
Telephone follow-up will be performed 3, 12 and 24
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
CHRU de Nancy
Vandœuvre-lès-Nancy, France
RECRUITINGRate 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)
Time frame: 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)
Time frame: 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)
Time frame: 24 months after inclusion
Number of B-lines measured in lung echography
Time frame: 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)
Time frame: 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)
Time frame: 24 months after inclusion
Rate of death from all causes
Time frame: 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)
Time frame: 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)
Time frame: 24 months after inclusion
Rate of hospitalisation for cardiovascular reason
Time frame: 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)
Time frame: 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)
Time frame: 24 months after inclusion
Rate of cardiovascular death
Time frame: 24 months after inclusion
NYHA (New York Heart Association) class measured
Time frame: 3, 12 and 24 months after inclusion
Natriuretic peptides
BNP or Nt-Pro BNP
Time frame: At baseline
Renal function
Assessed by glomerular filtration rate
Time frame: At baseline
Plasma volume
Calculated from haemoglobin and haematocrit value
Time frame: At baseline
Rate of bilirubin
Time frame: At baseline
Rate of ASAT
Time frame: At baseline
Rate of ALAT
Time frame: At baseline
Rate of V factor
Time frame: At baseline
Blood potassium concentration
Time frame: At baseline
Liver elastography value
Measured with Fibroscan®
Time frame: At inclusion
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: At inclusion and 3, 6 and 24 months
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