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

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Conditions studied: MASLD, Cardiovascular (CV) Risk, Subclinical Cardiovascular Impairments

In brief

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.

Key facts

Study ID

NCT07545343

Run by

First Affiliated Hospital, Sun Yat-Sen University

People needed

700

Starts

2026-06-01

Expected to finish

2030-05-31

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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