DUGi

Prognostic value of carbohydrate antigen 125 in transthyretin cardiac amyloidosis

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Background . Transthyretin amyloid cardiomyopathy (ATTR CM) is an increasingly recognised cause of restrictive cardiomyopathy and heart failure, particularly among older adults. Despite major advances in diagnostic imaging and disease modifying therapies, ATTR CM remains a progressive condition associated with high morbi dity and mortality. Accurate prognostic stratification is therefore essential to optimise management and monitor response to therapy. Current staging systems such as that by Gillmore rely primarily on cardiac biomarkers and renal function, which reflect myocardial stress and systemic burden but insufficiently capture extracardiac and hemodynamic features, particularly congestion. Carbohydrate antigen 125 (CA 125), traditionally used as a tumour marker, has emerged as a marker of serosal inflammation and fluid overload. Elevated CA 125 levels correlate with right sided congestion and adverse outcomes in heart failure, suggesting potential relevance in ATTR CM, a disease characterised by diastolic dysfunction, elevated filling pressures, and frequent serosal effusions. However, its prognostic value in ATTR CM has not yet been systematically assessed. Establishing CA 125 as a complementary bi omarker could enhance current staging systems, improve risk stratification, and facilitate more personalised management. Objectives . The primary objective is to determine whether elevated baseline CA 125 concentrations (>35 U/mL) are associated with increased all cause mortality over three years in patients with confirmed ATTR CM. Secondary objectives include assessing its association w ith heart failure hospitalisations and evaluating whether CA 125 improves the predictive performance of the Gillmore staging system. Methods . This protocol describes a single centre, prospective observational cohort study enrolling approximately 120 patients with confirmed ATTR CM. Baseline clinical, biochemical, and imaging data will be collected, and participants will be followed for three years. Descriptive and multivariate analyses will examine associations between CA 125 levels and outcomes to evaluate its role as a prognostic biomarker

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