About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization or in consultation

Patient with altered (left ventricular ejection fraction <40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction

Age ≥18 years

Patients having received complete information regarding the study design and having signed their informed consent form.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Clinical examination centered on congestion
Procedure/Surgery
Clinical examination centered on congestion (including the EVEREST, ASCEND and Ambrosy scores) will be performed during day hospitalization or consultation
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds
Procedure/Surgery
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/Surgery
Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation
Telephone follow-up
Other intervention
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

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled dayExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame