Chronic Heart Failure - COngestion eValuation

ConditionChronic Heart Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorPr. Nicolas GIRERD

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-COV study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF that are associated with the risk of all-cause death or hospitalization for acute HF within 24 months after day hospitalization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with chronic acute heart failure admitted in hospital for scheduled day hospitalization or consultation

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.

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 (including the EVEREST, ASCEND and Ambrosy scores) centered on congestion will be performed during day hospitalization or consultation
Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography
Procedure/Surgery
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds and liver elastography 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 visit (during 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 heart failure coming for scheduled day hospitalizationExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

Rate of death from all causes

composite endpoint : rate of death from all causes or hospitalisation for acute heart failure during 24 months following day hospitalization (with outcome 2)

Time frame