Heart Failure AcuteCLASH-HFNCT07345156
Congestion and LActate at diScHarge in Acute Heart Failure
An observational study of Heart Failure Acute and Discharge Follow-up Phone Calls, run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Acute, Discharge Follow-up Phone Calls, Mortality Prediction
- What is being tested?
- Lung Ultrasound Score and Lactate Blood Test
- How many people
- 350 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Fattouma Bourguiba Hospital of Monastir
Monastir, Monastir Governorate, 5000
Semir Nouira, Professor, +216 73 106 046, semir.nouira.urg@gmail.com
About this study
Official title: Validation of a Combined Score Combining the Lung Ultrasound Score and Lactate at Discharge for Predicting Early Events After 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.
Read the 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.
- Being tested
- Lung Ultrasound Score, Lactate Blood Test
- Keywords
- Lung Ultrasound Score, Lactate, Combined score, Acute Heart Failure, Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Ultrasound ScoreDiagnostic 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 TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Lung Ultrasound Score; Diagnostic Test: Lactate Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after hospital discharge
Secondary outcomes (1)
Time to first event
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.
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart Failure AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, Professor, Principal investigator, LR12SP18 ,University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345156
- Sponsor's protocol ID
- CLASH-HF study
- Acronym
- CLASH-HF
- Status last verified
- Jul 2026
- First submitted
- 24 Dec 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Núñez J, et al. Lactate and short-term mortality in heart failure. Int J Cardiol. 2019.
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.
PubMed 31667987Gheorghiade M, et al. Congestion in acute heart failure syndromes. Circulation. 2010.
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.
PubMed 28785469Dharmarajan 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.
PubMed 23340637Gheorghiade 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.
PubMed 23219302
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Combined Score Combining the Lung Ultrasound Score and Lactate at Discharge for Predicting Early Events After Acute Heart Failure
- ClinicalTrials.gov ID
- NCT07345156
- Acronym / sponsor ID
- CLASH-HF / CLASH-HF study
- Keywords
- Lung Ultrasound Score, Lactate, Combined score, Acute Heart Failure, Discharge
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated LUS-Lactate Risk Group | – | Diagnostic Test: Lung Ultrasound Score, Diagnostic Test: Lactate Blood TestPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Ultrasound ScoreA 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 test | Integrated LUS-Lactate Risk Group |
| Lactate Blood TestA 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. | Diagnostic test | Integrated LUS-Lactate Risk Group |
Primary outcome
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.
1 secondary outcome
Time to first event
Time frame: At 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- BackgroundNúñez J, et al. Lactate and short-term mortality in heart failure. Int J Cardiol. 2019.
- Background: PubMed 31667987Rivas-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.
- BackgroundGheorghiade M, et al. Congestion in acute heart failure syndromes. Circulation. 2010.
- Background: PubMed 28785469Savarese 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.
- Background: PubMed 23340637Dharmarajan 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.
- Background: PubMed 23219302Gheorghiade 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.
- Individual participant dataSharing planned: No
Related trials for Heart Failure Acute
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Semir Nouira, Professor principal investigator
LR12SP18 ,University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure Acute and Discharge Follow-up Phone Calls, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Semir Nouira Nouira, Professor (+216 73 106 046, semir.nouira.urg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of heart failure-related readmission or all-cause mortality (time frame: 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07345156, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.