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

Study acronym: EFICAC-TTR
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Completed without a posted recruiting period Show 9 more changesShow less
    • Trial sites expanded: 0 → 3 locations
    • Final enrollment: 47 participants (planned 102)
    • Primary completion date changed from estimate of Apr 2027 to Sep 10, 2026
    • Interventions modified
    • Start date changed from estimate of Jun 2026 to Feb 3, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 19 to 17
    • Study description expanded, about 114 words
    • Publications: details revised at 5 of 5 entries
  2. Start date: Jan 2026 to Jun 2026v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07343999
Lead Sponsor Universidad de Burgos
Collaborators: Hospital Universitario de Burgos
Conditions
(from sponsor)		 Transthyretin Cardiac Amyloidosis
Related terms Amyloid Neuropathies, Familial, Frailty
Enrollment 47 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov