NCT05089162

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

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Pr. Nicolas GIRERD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Heart Failure
• Reduced Ventricular Ejection Fraction

Interventions

Type	Name	Description
PROCEDURE	Clinical examination centered on congestion	Clinical examination centered on congestion (including the EVEREST, ASCEND and Ambrosy scores) will be performed during day hospitalization or consultation
PROCEDURE	Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds	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
PROCEDURE	Blood sample retrieved for biological assessment and biobanking	Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation
OTHER	Telephone follow-up	Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization or consultation
BEHAVIORAL	Kansas City Cardiomyopathy Questionnaire (KCCQ)	Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge

Timeline

• Start date: 2021-12-14
• Primary completion: 2028-12-14
• Completion: 2029-06-14
• First posted: 2021-10-22
• Last updated: 2023-06-05

Locations

1 site across 1 country: France