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Completed NCT07791589

Fibrosis and Metabolic Markers in Relation to PREVENT Cardiovascular Risk in MASLD

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease

Sex: All
Ages: 30 Years – 79 Years
Healthy volunteers: No
Enrollment: 271
Sponsor: Özgür Bahadır

Location: Göztepe Prof. Dr. Süleyman Yalçın City Hospital Istanbul

Summary

This retrospective observational study evaluates the relationship between non-invasive liver fibrosis and metabolic markers and estimated cardiovascular risk in adults with metabolic dysfunction-associated steatotic liver disease (MASLD). The primary objective is to assess the association between the Fibrosis-4 index (FIB-4) and 10-year cardiovascular disease risk estimated using the American Heart Association PREVENT equations, with particular attention to the effect of age on this association. Secondary analyses evaluate the Fibrosis-3 index (FIB-3), triglyceride-glucose index (TyG), and liver stiffness measurement (LSM) in relation to PREVENT-estimated risks of cardiovascular disease, atherosclerotic cardiovascular disease, and heart failure.

Eligibility Criteria

Inclusion Criteria: * Adults aged 30 to 79 years. Metabolic dysfunction-associated steatotic liver disease (MASLD), defined by hepatic steatosis on ultrasonography together with at least one cardiometabolic risk factor. Clinical data available for calculation of the PREVENT cardiovascular risk estimates within the supported input ranges. Exclusion Criteria: * Alternative causes of chronic liver disease. One or more required PREVENT input variables outside the supported ranges: systolic blood pressure 90-200 mmHg, total cholesterol 130-320 mg/dL, HDL cholesterol 20-100 mg/dL, eGFR 15-140 mL/min/1.73 m², or BMI 18.5-39.9 kg/m². Prior cardiovascular disease, defined as a history of stroke, coronary artery disease, heart failure, atrial fibrillation, or peripheral arterial disease.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07791589). StuddyBuddy aggregates publicly available trial information.