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Clinical Trials in China / NCT07545343
Starting soon Observational

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

NCT07545343 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Phase
Observational
Started
2026-06-01
Last updated
2026-04-22

Condition(s) studied

MASLDCardiovascular (CV) RiskSubclinical Cardiovascular Impairments

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of major adverse cardiovascular events (MACE) — 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.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong

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Other trials for the same condition

Lipidomic and Multi-Omics Profiling of Fatty Liver Disease in People With and Without HIV Starting soon
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Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07545343 on ClinicalTrials.gov ↗ ← All trials in China