Congestion and LActate at diScHarge in Acute Heart Failure

NCT07345156 | Not Yet Recruiting

• 1 other identifier: CLASH-HF study
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

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.

  30 days after hospital discharge

Secondary Outcomes (1)

• Time to first event

  At 30 days

Study Arms (1)

Integrated LUS-Lactate Risk Group

Patients classified according to a combined assessment of pulmonary congestion measured by lung ultrasound (LUS) and systemic tissue perfusion reflected by blood lactate levels at hospital discharge, aiming to capture both residual congestion and microcirculatory dysfunction and to improve prediction of early adverse outcomes.

Diagnostic Test: Lung Ultrasound Score; Diagnostic Test: Lactate Blood Test

Interventions

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.

Integrated LUS-Lactate Risk Group

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.

Integrated LUS-Lactate Risk Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Fattouma Bourguiba Hospital of Monastir

Monastir, Monastir Governorate, 5000, Tunisia

Location

Related Publications (6)

• Núñez J, et al. Lactate and short-term mortality in heart failure. Int J Cardiol. 2019.

  BACKGROUND

• Rivas-Lasarte M, Alvarez-Garcia J, Fernandez-Martinez J, Maestro A, Lopez-Lopez L, Sole-Gonzalez E, Pirla MJ, Mesado N, Mirabet S, Fluvia P, Brossa V, Sionis A, Roig E, Cinca J. Lung ultrasound-guided treatment in ambulatory patients with heart failure: a randomized controlled clinical trial (LUS-HF study). Eur J Heart Fail. 2019 Dec;21(12):1605-1613. doi: 10.1002/ejhf.1604. Epub 2019 Oct 31.

  PMID: 31667987 BACKGROUND

• Gheorghiade M, et al. Congestion in acute heart failure syndromes. Circulation. 2010.

  BACKGROUND

• Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.

  PMID: 28785469 BACKGROUND

• Dharmarajan K, Hsieh AF, Lin Z, Bueno H, Ross JS, Horwitz LI, Barreto-Filho JA, Kim N, Bernheim SM, Suter LG, Drye EE, Krumholz HM. Diagnoses and timing of 30-day readmissions after hospitalization for heart failure, acute myocardial infarction, or pneumonia. JAMA. 2013 Jan 23;309(4):355-63. doi: 10.1001/jama.2012.216476.

  PMID: 23340637 BACKGROUND

• Gheorghiade M, Vaduganathan M, Fonarow GC, Bonow RO. Rehospitalization for heart failure: problems and perspectives. J Am Coll Cardiol. 2013 Jan 29;61(4):391-403. doi: 10.1016/j.jacc.2012.09.038. Epub 2012 Dec 5.

  PMID: 23219302 BACKGROUND

Study Officials

• Semir Nouira, Professor

  LR12SP18 ,University of Monastir

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Semir Nouira Nouira, Professor

CONTACT

+216 73 106 046; semir.nouira.urg@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)