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

NCT07791589 | Completed

• 1 other identifier: IMU-MASLD-PREVENT-01
• Study Type: observational
• Target: 271
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

PREVENT; FIB-4; FIB-3; Triglyceride-Glucose Index; Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• Correlation between FIB-4 score and 10-year PREVENT-CVD risk

  FIB-4 score (unitless) was calculated as (age × AST)/(platelet count × √ALT). Ten-year PREVENT-CVD risk was expressed as a percentage (%) and calculated using the published sex-specific American Heart Association PREVENT base equation. Correlation was quantified using Spearman's rank correlation coefficient (rho; unitless, range -1 to +1). An age-adjusted partial Spearman correlation was also calculated.

  At the index clinical evaluation during the retrospective study period (January 1, 2024 to April 30, 2026)

Secondary Outcomes (11)

• Correlation between FIB-3 score and 10-year PREVENT-CVD risk

  At the index clinical evaluation during the retrospective study period (January 1, 2024 to April 30, 2026)

• Correlation between TyG index and 10-year PREVENT-CVD risk

  At the index clinical evaluation during the retrospective study period (January 1, 2024 to April 30, 2026)

• Correlation between liver stiffness measurement and 10-year PREVENT-CVD risk

  At the index clinical evaluation during the retrospective study period (January 1, 2024 to April 30, 2026)

• Correlation between FIB-4 score and 10-year PREVENT-ASCVD risk

  At the index clinical evaluation during the retrospective study period (January 1, 2024 to April 30, 2026)

• Correlation between FIB-3 score and 10-year PREVENT-ASCVD risk

  At the index clinical evaluation during the retrospective study period (January 1, 2024 to April 30, 2026)

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with MASLD who were evaluated at the study center between January 1, 2024 and April 30, 2026 and met the eligibility criteria for the primary PREVENT cardiovascular risk analysis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Özgür Bahadır: lead

Study Sites (1)

Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, 34722, Turkey (Türkiye)

Location

Related Publications (3)

• Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol. 2023 Dec;79(6):1542-1556. doi: 10.1016/j.jhep.2023.06.003. Epub 2023 Jun 24.

  PMID: 37364790 BACKGROUND

• Kariyama K, Kawanaka M, Nouso K, Hiraoka A, Toyoda H, Tada T, Ishikawa T, Wakuta A, Miyake N, Murakami S, Shiota S, Kumada T; Real-Life Practice Experts for HCC (RELPEC) Study Group. Fibrosis-3 Index: A New Score to Predict Liver Fibrosis in Patients With Nonalcoholic Fatty Liver Disease Without Age as a Factor. Gastro Hep Adv. 2022 Aug 2;1(6):1108-1113. doi: 10.1016/j.gastha.2022.07.012. eCollection 2022.

  PMID: 39131263 BACKGROUND

• Khan SS, Matsushita K, Sang Y, Ballew SH, Grams ME, Surapaneni A, Blaha MJ, Carson AP, Chang AR, Ciemins E, Go AS, Gutierrez OM, Hwang SJ, Jassal SK, Kovesdy CP, Lloyd-Jones DM, Shlipak MG, Palaniappan LP, Sperling L, Virani SS, Tuttle K, Neeland IJ, Chow SL, Rangaswami J, Pencina MJ, Ndumele CE, Coresh J; Chronic Kidney Disease Prognosis Consortium and the American Heart Association Cardiovascular-Kidney-Metabolic Science Advisory Group. Development and Validation of the American Heart Association's PREVENT Equations. Circulation. 2024 Feb 6;149(6):430-449. doi: 10.1161/CIRCULATIONAHA.123.067626. Epub 2023 Nov 10.

  PMID: 37947085 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assitant of Professor

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: June 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning after publication of the primary study results and available for 5 years.
• Access Criteria: Requests from qualified researchers with a methodologically sound proposal will be considered by the corresponding author and, where required, the relevant institution. Data will be shared only after appropriate institutional and ethical approval and in a de-identified form.

Locations

TU (1)