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Not yet recruiting NCT07545343

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

Conditions: MASLD Cardiovascular (CV) Risk Subclinical Cardiovascular Impairments

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

trial.available_in: БГ
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.
Who can participate
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
Locations 1
China (1)
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou , Guangdong
Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
31.05.2030
Registry ID
NCT07545343
Source
clinicaltrials.gov
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