RecruitingNCT06993220

Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients

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

Sponsor

Consorci Sanitari Integral

Enrollment

500 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the best way to measure how much fluid ('congestion') remains in the body at hospital discharge after treatment for an acute heart failure episode, since residual fluid is linked to higher chances of readmission. **You may be eligible if...** - You are 18 or older - You have been hospitalized for new or worsening heart failure - You have significant symptoms (NYHA class III–IV) and signs of fluid overload such as swelling, shortness of breath, or elevated heart failure blood markers - You are able to give informed consent **You may NOT be eligible if...** - You have a known blood infection (septicemia) - Your kidney filtration rate is very low (below 15 mL/min) - You have active heart muscle inflammation (myocarditis) - You have had a heart transplant or have a ventricular assist device - You have congenital heart disease - Your expected survival is less than 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTEvaluation 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.