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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07345156
Acronym
CLASH-HF
Enrollment
350
Registered
2026-01-15
Start date
2026-01-01
Completion date
2026-12-30
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure Acute, Discharge Follow-up Phone Calls, Mortality Prediction

Keywords

Lung Ultrasound Score, Lactate, Combined score, Acute Heart Failure, Discharge

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTLung Ultrasound Score

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.

DIAGNOSTIC_TESTLactate Blood 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.

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Composite of heart failure-related readmission or all-cause mortality30 days after hospital dischargeA 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

MeasureTime frameDescription
Time to first eventAt 30 daysIncludes 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.

Countries

Tunisia

Contacts

Primary ContactSemir Nouira Nouira, Professor
semir.nouira.urg@gmail.com+216 73 106 046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026