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Recruiting NCT06993220

Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Evaluation of residual congestion at discharge.
Who it may be relevant to
Registry conditions: Acute Heart Failure (AHF), Congestive Heart Failure(CHF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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, N

Primary outcome measures

  • Worsening heart failure or cardiovascular death [Time frame: 6 months after hospital discharge]
Secondary outcome measures (3)
  • all-cause death [Time frame: 6 months after hospital discharge]
  • time to first heart failure event [Time frame: 6 months after hospital discharge]
  • number of heart failure events [Time frame: 6 months after hospital discharge]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years.
  • Patients hospitalized for new onset heart failure or worsening heart failure defined by:
  • Symptoms classified as New York Heart Association class III or IV.
  • Clinical or instrumental signs of volume overload (e.g., dyspnea with evidence of pulmonary congestion on X-rays or lung ultrasound, pitting edema, and jugular venous distension).
  • Elevated NT-proBNP levels within the first 24 hours of admission (cutoff values: 450 ng/L for patients < 50 years; >900 ng/L for patients aged 50-75 years; >1800 ng/L for patients >75 years).
  • Ability to provide informed consent.

Exclusion criteria

  • Known diagnosis of septicemia.
  • Glomerular filtration rate < 15 ml/min.
  • Life expectancy < 6 months.
  • Active myocarditis.
  • Heart transplant recipients.
  • Patients with ventricular assist devices.
  • Congenital heart diseases.
  • Moderate-to-severe liver disease (Child-Pugh B-C).
  • Patients that will not be followed up by the Heart Failure Unit.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Complex Hospitalari Universitari Moisès Broggi — Sant Joan Despí

Identifiers

NCT: NCT06993220 · 24/53

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗