Integrated Ultrasound-Derived Fat Fraction and 2D/4D HeartAI for Cardiovascular Risk Management in Patients With MASLD

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

700 Participants
are grouped into 2 trial groups
Group A: Group 1: MASLD participants with elevated liver fat burden
Group B: Group 2: MASLD participants with lower liver fat burden

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
Baseline, 6 months, 12 months, and 36 months

Other outcomes

Sponsors and contacts

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