MASLDMUCHAINCT07545343
Integrated Ultrasound-Derived Fat Fraction and 2D/4D HeartAI for Cardiovascular Risk Management in Patients With MASLD
An observational study of MASLD and Cardiovascular (CV) Risk, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This prospective observational cohort study aims to evaluate the association between liver fat fraction measured by ultrasound-derived fat fraction (UDFF) and cardiac functional parameters assessed by 2D and 4D HeartAI in adult patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MASLD, Cardiovascular (CV) Risk, Subclinical Cardiovascular Impairments
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 May 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 to 75 years with metabolic dysfunction-associated steatotic liver disease (MASLD), diagnosed by imaging or biopsy and with at least one cardiometabolic risk factor, who are recruited from the Department of Ultrasound, The First Affiliated Hospital of Sun Yat-sen University. This is a prospective observational cohort study with baseline and follow-up assessments at 6, 12, and 36 months.
Who may be able to join
- Adults aged 18 to 75 years
- Diagnosis of MASLD based on imaging or biopsy
- Presence of at least one cardiometabolic risk factor, such as BMI ≥25 kg/m², type 2 diabetes mellitus, or dyslipidemia
- No contraindication to ultrasound imaging
Who cannot join
- Significant alcohol consumption: >20 g/day for women or >30 g/day for men Secondary causes of hepatic steatosis, such as viral hepatitis or autoimmune liver disease
- Known advanced heart failure (New York Heart Association class III-IV)
- Recent cardiovascular event within 6 months
- Pregnancy
- Inability to complete follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
About this study
Official title: Integration of Ultrasound-Derived Fat Fraction With 2D and 4D HeartAI for Cardiovascular Risk Management in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Observational Cohort Study
This prospective observational cohort study aims to evaluate the association between liver fat fraction measured by ultrasound-derived fat fraction (UDFF) and cardiac functional parameters assessed by 2D and 4D HeartAI in adult patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo baseline assessment and repeat evaluations at 6, 12, and 36 months. The study will assess the diagnostic performance of integrated UDFF-HeartAI analysis for detecting subclinical cardiac abnormalities and identify predictors of cardiovascular risk progression and major adverse cardiovascular events in patients with MASLD.
- Keywords
- Ultrasound-Derived Fat Fraction, Echocardiography, Cardiovascular Events, Major Adverse Cardiovascular Events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: MASLD participants with elevated liver fat burden | Participants with higher UDFF values. | |
| Group 2: MASLD participants with lower liver fat burden | Participants with lower UDFF values. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiovascular events (MACE)
Composite of cardiovascular death and non-fatal cardiovascular events, including non-fatal acute myocardial infarction, hospitalization for heart failure, unstable angina, hospitalization for atherosclerotic vascular disease, non-fatal stroke, transient ischemic attack, or lower limb ischemia.
Measured: Up to 36 months
Secondary outcomes (1)
Subclinical cardiac dysfunction
Defined by abnormalities such as left ventricular ejection fraction <50% or abnormal left ventricular global longitudinal strain.
Measured: Baseline, 6 months, 12 months, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjie Wan, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545343
- Sponsor's protocol ID
- SYSUFH-MASLD-2026-01
- Acronym
- MUCHAI
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Ultrasound-Derived Fat Fraction With 2D and 4D HeartAI for Cardiovascular Risk Management in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07545343
- Acronym / sponsor ID
- MUCHAI / SYSUFH-MASLD-2026-01
- Keywords
- Ultrasound-Derived Fat Fraction, Echocardiography, Cardiovascular Events, Major Adverse Cardiovascular Events
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 22 Apr 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.
This prospective observational cohort study aims to evaluate the association between liver fat fraction measured by ultrasound-derived fat fraction (UDFF) and cardiac functional parameters assessed by 2D and 4D HeartAI in adult patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo baseline assessment and repeat evaluations at 6, 12, and 36 months. The study will assess the diagnostic performance of integrated UDFF-HeartAI analysis for detecting subclinical cardiac abnormalities and identify predictors of cardiovascular risk progression and major adverse cardiovascular events in patients with MASLD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: MASLD participants with elevated liver fat burden | – | –Participants with higher UDFF values. |
| Group 2: MASLD participants with lower liver fat burden | – | –Participants with lower UDFF values. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 to 75 years with metabolic dysfunction-associated steatotic liver disease (MASLD), diagnosed by imaging or biopsy and with at least one cardiometabolic risk factor, who are recruited from the Department of Ultrasound, The First Affiliated Hospital of Sun Yat-sen University. This is a prospective observational cohort study with baseline and follow-up assessments at 6, 12, and 36 months.
Key inclusion criteria (4 listed)
- Adults aged 18 to 75 years
- Diagnosis of MASLD based on imaging or biopsy
- Presence of at least one cardiometabolic risk factor, such as BMI ≥25 kg/m², type 2 diabetes mellitus, or dyslipidemia
- No contraindication to ultrasound imaging
Key exclusion criteria (5 listed)
- Significant alcohol consumption: >20 g/day for women or >30 g/day for men Secondary causes of hepatic steatosis, such as viral hepatitis or autoimmune liver disease
- Known advanced heart failure (New York Heart Association class III-IV)
- Recent cardiovascular event within 6 months
- Pregnancy
- Inability to complete follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of major adverse cardiovascular events (MACE)
Time frame: Up to 36 months
Composite of cardiovascular death and non-fatal cardiovascular events, including non-fatal acute myocardial infarction, hospitalization for heart failure, unstable angina, hospitalization for atherosclerotic vascular disease, non-fatal stroke, transient ischemic attack, or lower limb ischemia.
1 secondary outcome
Subclinical cardiac dysfunction
Time frame: Baseline, 6 months, 12 months, and 36 months
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 22 Apr 2026.
- Individual participant dataSharing planned: No
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NAFLD Clinical Care Pathway
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MASLD
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.
The record lists no contact. Use the official record to reach the sponsor.
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 MASLD and Cardiovascular (CV) Risk, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 4 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: opening soon, as of the sponsor's last update on 22 Apr 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiovascular events (MACE) (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.