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

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.

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Key information

Conditions

MASLD Cardiovascular (CV) Risk Subclinical Cardiovascular Impairments

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of major adverse cardiovascular events (MACE)

Time frame: 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.

Secondary outcomes

Subclinical cardiac dysfunction

Time frame: Baseline, 6 months, 12 months, and 36 months

Defined by abnormalities such as left ventricular ejection fraction <50% or abnormal left ventricular global longitudinal strain.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study 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

Acronym: MUCHAI

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Apr 22, 2026
Registry last updated: Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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