NCT07545343Not yet recruiting
Integrated Ultrasound-Derived Fat Fraction and 2D/4D HeartAI for Cardiovascular Risk Management in Patients With MASLD
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
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 16 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 May 2030
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07545343
What you commit to
- Study type: Observational
- Planned participants: 700
- From 1 Jun 2026 to the primary completion date, 31 May 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Recent cardiovascular event within 6 months
- Pregnancy
- Inability to complete follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.