RecruitingRecruiting
Congestion and LActate at diScHarge in Acute Heart Failure
NCT07345156 · University of Monastir
In plain English
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Official title
Validation of a Combined Score Combining the Lung Ultrasound Score and Lactate at Discharge for Predicting Early Events After Acute Heart Failure
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.
Eligibility criteria
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.
Study design
Enrollment target: 350 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-01-01
Estimated completion: 2026-12-30
Last updated: 2026-07-15
Interventions
Diagnostic Test: Lung Ultrasound ScoreDiagnostic Test: Lactate Blood Test
Primary outcomes
- • Composite of heart failure-related readmission or all-cause mortality (30 days after hospital discharge)
Sponsor
University of Monastir · other
Contacts & investigators
ContactSemir Nouira Nouira, Professor · contact · semir.nouira.urg@gmail.com · +216 73 106 046
InvestigatorSemir Nouira, Professor · principal_investigator, LR12SP18 ,University of Monastir
All locations (1)
Fattouma Bourguiba Hospital of MonastirRecruiting
Monastir, Monastir Governorate, Tunisia