NCT05097898

Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique à Fraction d'éjection préservée. CHF-COV Preserved (Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Central Hospital, Nancy, France · 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 Preserved study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with preserved 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
• Preserved Ejection Fraction

Interventions

Type	Name	Description
PROCEDURE	Clinical examination centered on congestion	Clinical examination centered on congestion (including the EVEREST, Ambrosy and ASCEND score) will be performed during day hospitalization or consultation
PROCEDURE	Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography	Cardiac, vena cava, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds and liver elastography are optional/Cardiac echo is optional for patients included in consultation
PROCEDURE	Blood and urine sample retrieved for biological assessment and biobanking	Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation/ Urine analysis is optional for patients included in consultation
OTHER	Telephone follow-up	Telephone follow-up will be performed 3, 12 and 24
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: 2022-08-10
• Primary completion: 2028-12-10
• Completion: 2029-06-10
• First posted: 2021-10-28
• Last updated: 2023-06-05

Locations

1 site across 1 country: France