NCT06993220

Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients

Multiparametric Assessment of Residual Congestion at Discharge in Patients With Acute Heart Failure

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Consorci Sanitari Integral · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Treatment of congestion is one of the main goals in patients hospitalized for acute heart failure. Nevertheless, current evidence shows that decongestion is often not achieved and that residual congestion at discharge is strongly associated with poor outcomes. While this association has been demonstrated, previous studies have primarily focused on single parameters of congestion (physical examination, biomarkers, or imaging features). The aim of the study is to assess residual congestion at discharge using a multiparametric approach and to compare the prognostic value of each evaluation strategy. Additionally, the analysis will be supported by artificial intelligence to develop a multiparametric prognostic algorithm that can provide an improved predictive model compared to standard statistical approaches.

Conditions

• Acute Heart Failure (AHF)
• Congestive Heart Failure(CHF)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Evaluation of residual congestion at discharge	Evaluation of residual congestion at discharge will be made using: * Clinical variables: composite congestion score calculated by summing the individual scores for orthopnoea, jugular venous distension and pedal oedema; * Imaging variables: non-invasive left ventricular filling pressure, number of LUS B lines and the presence of pleural effusion, Venous Excess UltraSound (VExUS) score; * Laboratory variables: hemoglobin and hematocrit, NT-proBNP, CA-125, ST2, troponin T, creatinine, AST, ALT, Na, K, urea, bilirubin, C-reactive protein.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-06-01
• Completion: 2027-01-01
• First posted: 2025-05-28
• Last updated: 2025-07-18

Locations

1 site across 1 country: Spain