Design and Rationale of the FICAPP Study: Frailty in Cardiac Amyloidosis: Profiling the Phenotype

BACKGROUND & AIM: Cardiac amyloidosis is an infiltrative cardiomyopathy associated with significant morbidity and mortality. Frailty, a biologic syndrome of decreased physiologic reserve, may be common and clinically significant in this population, yet remains insufficiently characterised. We aim to determine the prevalence and characteristics of frailty among adults with cardiac amyloidosis, and examine its association with functional status, quality of life, and disease severity. METHODS & DESIGN: As a prospective, observational, single-centre cohort study, adults with confirmed cardiac amyloidosis will undergo standardised frailty assessment. The prevalence of physical frailty (≥3 criteria) and cognitive frailty (≥2 frailty criteria plus mild cognitive impairment (MoCA <26)) will be evaluated, and the distribution of individual criteria summarised. Disease characterisation will include functional status, quality of life, disease staging, and biomarkers at baseline and 12-month follow-up. Associations between frailty and clinical variables will be explored using descriptive and univariate analyses. EXPECTED RESULTS: We anticipate a high prevalence of frailty among individuals with cardiac amyloidosis, with greater frailty burden associated with worse functional status, diminished quality of life, multisystem disease and advanced disease severity. CONCLUSIONS: The study will deliver a pragmatic, clinically aligned characterisation of frailty in cardiac amyloidosis and support the development of hypotheses to guide the design of future longitudinal and interventional studies in cardiac amyloidosis.