NCT03327532

Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE)

Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d'Une Hospitalisation Pour Insuffisance Cardiaque aigüe

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The AHF-CORE study is a prospective, non-randomized, multicenter regional study. The main objective of the AHF-CORE study is to identify congestion markers (clinical, biological and ultrasound) at the beginning and at the end of hospitalization for acute heart failure that are more strongly associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge. Secondary objectives are: * Quantify the variations in congestion markers between the beginning and end of hospitalization for acute heart failure. * Assess the correlation between changes in congestion markers between the beginning and end of hospitalization. * Identify the congestion markers at the beginning of hospitalization that are most strongly associated with residual congestion at the end of hospitalization. * Identify the added value of ultrasound and biological markers of congestion in addition to clinical variables for the prediction of all-cause death or hospitalization for acute heart failure at 3 months after hospital discharge. * Identify the association of ultrasound and biologic congestion markers assessed at admission and final discharge with NYHA class at 3 months after hospital discharge

Detailed description

Congestion (clinical, biological and ultrasound evaluation) will be quantified at inclusion within 72 hours of admission and before hospital discharge. Follow-up at 3 months of hospital discharge will be performed through telephone interviews. Vital status and rehospitalization status will be collected. Throughout the study, patients will continue to be treated according to usual routine care, regardless of their level of congestion. There will be no modification of treatment according to the congestion data acquired within the setting of the study.

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Clinical examination centered on congestion	Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital
PROCEDURE	Cardio-pulmonary and peritoneal ultrasound	Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital
BIOLOGICAL	Blood sample retrieved for biological assessment and biobanking	Blood sample collection will be performed within 72 hours of admission and before discharge from hospital
OTHER	Telephone interview	Telephone interview will be performed 3, 12 and 24 months after discharge from hospital
BIOLOGICAL	Urinary sample retrieved for biological assessment and biobanking	Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital
PROCEDURE	jugular and renal ultrasound (optional)	optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital

Timeline

• Start date: 2018-02-13
• Primary completion: 2024-05-01
• Completion: 2026-02-01
• First posted: 2017-10-31
• Last updated: 2023-08-31

Locations

2 sites across 1 country: France