Fact CheckerSign in

NCT07345156Recruiting

Congestion and LActate at diScHarge in Acute Heart Failure

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

Source: ClinicalTrials.gov · Last updated 15 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
350 (estimated)
First submitted
24 Dec 2025
Start date
Jan 2026
Primary completion date
Dec 2026
Lead sponsor
University of Monastir
NCT number
NCT07345156

What you commit to

  • Study type: Observational
  • Planned participants: 350
  • From Jan 2026 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Septic shock/severe active infection at the time of discharge.
  • Severe cirrhosis/advanced liver failure.

Other

  • Hypoxemia or respiratory distress requiring high-flow oxygen/ventilation at the scheduled time of discharge.
  • Refusal to participate.
  • Technical impossibility of LUS.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fattouma Bourguiba Hospital of Monastir
Coordinator of this site? Confirm its status
MonastirTunisiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.