Clinical Research Directory

EFICAC-TTR Trial: Exercise and Nutritional Supplementation in Transthyretin Cardiac Amyloidosis

Sponsor: Universidad de Burgos

Summary

Transthyretin cardiac amyloidosis (TTR-CA) is a systemic cardiac disease that predominantly affects older adults and is frequently associated with reduced physical capacity, muscle weakness, frailty, and impaired quality of life. Although disease-modifying treatments can slow cardiac disease progression, functional and nutritional impairment remain important unmet clinical needs. EFICAC-TTR is a prospective, randomized, multicenter study designed to evaluate the effects of a 12-week home-based multicomponent exercise program combined with nutritional supplementation in adults aged 70 years or older with confirmed TTR-CA. A total of 47 participants were randomized to one of three parallel groups: (1) usual medical care; (2) a home-based multicomponent exercise program plus microcrystalline cellulose control supplementation; or (3) the same exercise program plus creatine monohydrate (3 g/day) and beta-hydroxy-beta-methylbutyrate (HMB, 3 g/day). The primary functional outcomes are change in 6-minute walk test distance and handgrip strength from baseline to 12 weeks. Secondary outcomes include body composition, frailty, quality of life, and nutritional and clinical variables. Mechanistic biomarkers are assessed as exploratory outcomes. The study aims to determine whether combining exercise with nutritional supplementation can improve functional capacity and related health outcomes in older adults with TTR-CA.

Official title: A Prospective, Randomized, Multicenter Clinical Trial on the Effect of a Home-Based Multicomponent Exercise Program Combined With Nutritional Supplementation in Patients With Transthyretin Cardiac Amyloidosis

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