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NOT YET RECRUITING
NCT07345156

Congestion and LActate at diScHarge in Acute Heart Failure

Sponsor: University of Monastir

View on ClinicalTrials.gov

Summary

Acute heart failure (AHF) is a leading cause of hospitalization and is associated with high short-term morbidity and mortality, with 20-30% of patients experiencing rehospitalization or death within 30 days. Early adverse events often reflect incomplete recovery, highlighting the need for improved risk stratification after clinical stabilization .Current prognostic approaches mainly focus on hemodynamic congestion. Persistent pulmonary congestion at discharge is a strong predictor of poor outcomes, but these markers primarily assess macrocirculatory abnormalities and do not capture microcirculatory dysfunction, which may persist despite apparent clinical improvement. Lung ultrasound, through the Lung Ultrasound Score (LUS), provides a validated assessment of pulmonary congestion and has demonstrated prognostic value in AHF. However, LUS does not reflect systemic tissue perfusion. In contrast, blood lactate is a robust marker of tissue hypoperfusion, and even mild elevations have been associated with worse outcomes in AHF. A combined score integrating LUS and lactate may therefore better reflect the dual pathophysiology of AHF-persistent congestion and impaired tissue perfusion-and improve prediction of early adverse events. This protocol aims to validate the prognostic value of this combined score for predicting 30-day rehospitalization or death in patients hospitalized for AHF, with the hypothesis that it outperforms LUS alone.

Official title: Validation of a Combined Score Combining the Lung Ultrasound Score and Lactate at Discharge for Predicting Early Events After Acute Heart Failure

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

350

Start Date

2026-01-01

Completion Date

2026-12-30

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Lung Ultrasound Score

A semi-quantitative ultrasound-based measure of pulmonary congestion that estimates interstitial and alveolar edema by counting B-lines across predefined lung zones, providing a simple and reproducible assessment of residual pulmonary congestion in heart failure patients.

DIAGNOSTIC_TEST

Lactate Blood Test

A biochemical marker reflecting the balance between tissue oxygen delivery and consumption, with elevated levels indicating impaired tissue perfusion or increased anaerobic metabolism, and associated with worse outcomes in acute heart failure even in the absence of overt shock.

Locations (1)

Fattouma Bourguiba Hospital of Monastir

Monastir, Monastir Governorate, Tunisia