CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)

Not Applicable

Recruiting

• Conditions: Chronic Heart Failure; Reduced Ventricular Ejection Fraction

• Registration Number: NCT05089162
• Lead Sponsor: Pr. Nicolas GIRERD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-22
• Study Start: 2021-12-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05
• Primary Completion: 2028-12-14
• Study Completion: 2029-06-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of death from all causes	24 months after day hospitalization or consultation	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)
Rate of day-hospital or in-home IV diuretics injection for acute HF	24 months after day hospitalization or consultation	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 1 and 2)
Rate of hospitalisation for acute heart failure	24 months after day hospitalization or consultation	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 1 and 3)

Secondary Outcome Measures

Name	Time	Method
Circulating NtProBNP	At inclusion
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)	At inclusion and 3, 6 and 24 months
Rate of ASAT	At inclusion
Liver elastography value	At inclusion	Measured with Fibroscan®
Rate of hospitalisation for acute heart failure	24 months after day hospitalization or consultation	composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 10)
Rate of hospitalisation for cardiovascular reason	24 months after day hospitalization or consultation
Rate of cardiovascular death	24 months after day hospitalization or consultation
Natriuretic peptides	At inclusion	BNP or Nt-Pro BNP
Renal function	At inclusion	Assessed by glomerular filtration rate
Plasma volume	At inclusion	calculated from haemoglobin and haematocrit value
Rate of day-hospital or in-home IV diuretics injection for acute HF	24 months after day hospitalization or consultation	composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 7)
Rate of ALAT	At inclusion
Blood potassium concentration	At inclusion
Rate of death from all causes	3, 12 and 24 months after day hospitalization or consulation	composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 11)
NYHA (New York Heart Association) class measured	3, 12 and 24 months after day hospitalization or consultation
Rate of Bilirubin	At inclusion
Rate of V factor	At inclusion

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Vandoeuvre Les Nancy, France