Not Yet RecruitingNot Applicable

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

China700 participantsStarted 2026-06-01

Plain-language 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). 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Incidence of major adverse cardiovascular events (MACE)

Timeframe: Up to 36 months

Trial details

NCT IDNCT07545343

SponsorFirst Affiliated Hospital, Sun Yat-Sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-05-31

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