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

Recruiting · NCT05089162 · Interventional (participants receive a specific treatment) · Lead sponsor: Pr. Nicolas GIRERD

View the official record on ClinicalTrials.gov →

Heart failure

Interventions studied

Blood sample retrieved for biological assessment and biobankingCardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasoundsClinical examination centered on congestionKansas City Cardiomyopathy Questionnaire (KCCQ)Telephone follow-up

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

CHRU de Nancy - Vandœuvre-lès-Nancy, France

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →