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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Subclinical cardiac dysfunction
Defined by abnormalities such as left ventricular ejection fraction \<50% or abnormal left ventricular global longitudinal strain.
Sponsors and contacts
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