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NCT Number: NCT07345156

Congestion and LActate at diScHarge in Acute Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fattouma Bourguiba Hospital of Monastir

Monastir, Monastir Governorate, 5000, Tunisia

Location status: Recruiting

Location contact

Semir Nouira, Professor

CONTACT

[email protected]

+216 73 106 046

About this study

This is a prospective, multicenter, observational cohort study including adults (≥18 years) hospitalized for acute decompensated heart failure who were deemed clinically stable and scheduled for discharge within 24 hours. Patients with active severe infection or septic shock, significant hypoxemia or respiratory distress requiring advanced oxygen or ventilatory support, advanced liver disease, refusal to participate, or technical inability to perform lung ultrasound were excluded. At discharge, pulmonary congestion was assessed using lung ultrasound with a standardized 8-zone protocol, and venous blood lactate was measured under resting conditions. Demographic data, heart failure phenotype, discharge vital signs, laboratory values, treatments, and hospitalization characteristics were collected. The primary endpoint was a composite of heart failure-related readmission or all-cause mortality within 30 days after discharge. Secondary endpoints included all-cause readmission, emergency department visits at 30 days, and time to first event. Follow-up was conducted at 30 days using a standardized telephone interview and review of medical records, with strict criteria applied for the definition of heart failure readmission.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • Technical impossibility of LUS.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 30 days after hospital discharge

    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.

Secondary outcomes

  1. Time to first event

    Time frame: At 30 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Semir Nouira Nouira, Professor

CONTACT

[email protected]

+216 73 106 046

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Acronym: CLASH-HF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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