Integrated Ultrasound-Derived Fat Fraction and 2D/4D HeartAI for Cardiovascular Risk Management in Patients With MASLD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: MASLD, Cardiovascular (CV) Risk, Subclinical Cardiovascular Impairments. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integration of Ultrasound-Derived Fat Fraction With 2D and 4D HeartAI for Cardiovascular Risk Management in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Observational Cohort Study
Overview
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.
Primary outcome measures
- Incidence of major adverse cardiovascular events (MACE) [Time frame: Up to 36 months]
Secondary outcome measures (1)
- Subclinical cardiac dysfunction [Time frame: Baseline, 6 months, 12 months, and 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07545343 · SYSUFH-MASLD-2026-01