Clinical trial NCT05089162: CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
Official title: Evaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection altérée ou modérément altérée CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Heart Failure
Reduced Ventricular Ejection Fraction
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: Inclusion Criteria:

* 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.
* Patient affiliated to or beneficiary of a social security scheme.

Exclusion Criteria:

* 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.
* Pregnant woman, parturient or nursing mother
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* Adult person who is unable to give consent
* Person deprived of liberty by a judicial or administrative decision,
* Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.

Primary outcomes:
measure: Rate of death from all causes
timeFrame: 24 months after day hospitalization or consultation
measure: Rate of hospitalisation for acute heart failure
timeFrame: 24 months after day hospitalization or consultation
measure: Rate of day-hospital or in-home IV diuretics injection for acute HF
timeFrame: 24 months after day hospitalization or consultation
Secondary outcomes:
measure: Rate of death from all causes
timeFrame: 24 months after day hospitalization or consultation
measure: Rate of hospitalisation for acute heart failure
timeFrame: 24 months after day hospitalization or consultation
measure: Rate of death from all causes
timeFrame: 24 months after day hospitalization or consultation
measure: Rate of hospitalisation for acute heart failure
timeFrame: 24 months after day hospitalization or consultation
measure: Rate of day-hospital or in-home IV diuretics injection for acute HF
timeFrame: 24 months after day hospitalization or consultation
measure: Rate of hospitalisation for cardiovascular reason
timeFrame: 24 months after day hospitalization or consultation
measure: Rate of death from all causes
timeFrame: 3, 12 and 24 months after day hospitalization or consulation
measure: Rate of hospitalisation for acute heart failure
timeFrame: 24 months after day hospitalization or consultation
measure: Rate of cardiovascular death
timeFrame: 24 months after day hospitalization or consultation
measure: NYHA (New York Heart Association) class measured
timeFrame: 3, 12 and 24 months after day hospitalization or consultation
measure: Natriuretic peptides
timeFrame: At inclusion
measure: Renal function
timeFrame: At inclusion
measure: Plasma volume
timeFrame: At inclusion
measure: Rate of Bilirubin
timeFrame: At inclusion
measure: Rate of ASAT
timeFrame: At inclusion
measure: Rate of ALAT
timeFrame: At inclusion
measure: Rate of V factor
timeFrame: At inclusion
measure: Blood potassium concentration
timeFrame: At inclusion
measure: Circulating NtProBNP
timeFrame: At inclusion
measure: Liver elastography value
timeFrame: At inclusion
measure: Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: At inclusion and 3, 6 and 24 months
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CHRU de Nancy
Study officials:
References: