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

NCT07545343 | Not Yet Recruiting DMC

• 1 other identifier: SYSUFH-MASLD-2026-01
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MASLD; Cardiovascular (CV) Risk; Subclinical Cardiovascular Impairments

Keywords

Ultrasound-Derived Fat Fraction; Echocardiography; Cardiovascular Events; Major Adverse Cardiovascular Events

Outcome Measures

Primary Outcomes (1)

• Incidence of major adverse cardiovascular events (MACE)

  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.

  Up to 36 months

Secondary Outcomes (1)

• Subclinical cardiac dysfunction

  Baseline, 6 months, 12 months, and 36 months

Study Arms (2)

Group 1: MASLD participants with elevated liver fat burden

Participants with higher UDFF values.

Group 2: MASLD participants with lower liver fat burden

Participants with lower UDFF values.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 to 75 years with metabolic dysfunction-associated steatotic liver disease (MASLD), diagnosed by imaging or biopsy and with at least one cardiometabolic risk factor, who are recruited from the Department of Ultrasound, The First Affiliated Hospital of Sun Yat-sen University. This is a prospective observational cohort study with baseline and follow-up assessments at 6, 12, and 36 months.

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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)