Congestion and LActate at diScHarge in Acute Heart Failure

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Monastir

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Hospitalization for acute heart failure/decompensation (clinical diagnosis + imaging/laboratory tests according to local practice).

Patient deemed ready for discharge (decision made by the team, discharge within 24 hours).

Disqualifiers

Septic shock/severe active infection at the time of discharge.

Hypoxemia or respiratory distress requiring high-flow oxygen/ventilation at the scheduled time of discharge.

Severe cirrhosis/advanced liver failure.

Refusal to participate.

Trial population

Patients Hospitalized for Acute Decompensated Heart Failure: Adults admitted due to worsening heart failure symptoms requiring inpatient management, including clinical and/or imaging or laboratory confirmation of decompensation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lung Ultrasound Score

    Diagnostic test

    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.

  • Lactate Blood Test

    Diagnostic 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.

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: Integrated LUS-Lactate Risk Group2 interventions

Trial outcomes

Primary outcomes

1

Composite of heart failure-related readmission or all-cause mortality

A combined outcome of heart failure-related rehospitalization or all-cause death within 30 days after hospital discharge, used to assess early adverse events in acute heart failure patients.

Time frame
30 days after hospital discharge

Secondary outcomes

1

Time to first event

Includes all-cause hospital readmission, emergency department visits within 30 days, and time to the first adverse event, used to evaluate broader short-term outcomes after discharge in acute heart failure patients.

Time frame
At 30 days

Other outcomes

Sponsors and contacts

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