NCT05089149

Chronic Heart Failure - COngestion eValuation

Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique. CHF-COV (Chronic Heart Failure - 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-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.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Clinical examination centered on congestion	Clinical examination (including the EVEREST, ASCEND and Ambrosy scores) centered on congestion will be performed during day hospitalization or consultation
PROCEDURE	Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography	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
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 visit (during 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

2 sites across 1 country: France