Transthyretin cardiac amyloidosis (TTR-CA) is a heart disease that mainly affects older adults and often leads to reduced physical capacity, muscle weakness, frailty, and a decline in quality of life. While current medical treatments can slow disease progression, they do not fully address functional limitations or muscle deterioration.
The EFICAC-TTR study is a prospective, randomized, multicenter clinical trial designed to evaluate whether a combined non-pharmacological intervention can improve physical function in patients aged 70 years or older with confirmed TTR-CA.
A total of 102 participants will be randomly assigned to one of three groups: (1) usual medical care, (2) a home-based multicomponent exercise program combined with fiber supplementation, or (3) the same exercise program combined with creatine monohydrate and β-hydroxy-β-methylbutyrate (HMB) supplementation. The exercise program is adapted to each participant's functional level and is performed at home.
The main outcomes of the study are changes in walking capacity, measured by the 6-minute walk test, and muscle strength, assessed by handgrip strength after 12 weeks. Secondary outcomes include changes in body composition, frailty, quality of life, and clinical events, while mechanistic biomarkers are assessed as exploratory outcomes.
This study aims to determine whether combining exercise with nutritional supplementation can safely improve functional capacity and overall health in older adults with transthyretin cardiac amyloidosis.
Age ≥70 years.
Confirmed diagnosis of transthyretin cardiac amyloidosis (TTR-CA) based on positive bone scintigraphy with diphosphonates (Perugini grade 2 or 3) and absence of monoclonal protein.
Clinical stability during the 4 weeks prior to enrollment.
Ability to understand the study procedures and provide written informed consent.
Light-chain (AL) amyloidosis or other non-TTR amyloidosis variants.
Absolute medical contraindication to moderate-intensity exercise.
Severe comorbid conditions with an estimated life expectancy <6 months.
Severe cognitive impairment (Mini-Mental State Examination score <20).
Parallel
Usual Care
Other interventionStandard clinical management for transthyretin cardiac amyloidosis according to routine cardiology practice.
Home-Based Multicomponent Exercise Program
BehavioralA 12-week home-based multicomponent exercise program adapted from the Vivifrail model, including strength, balance, mobility, and endurance exercises tailored to individual functional capacity.
Fiber Supplementation (Microcrystalline Cellulose)
Dietary supplementDaily oral supplementation with microcrystalline cellulose, used as a nutritionally inert control supplement to match supplementation procedures.
Creatine and HMB Supplementation
Dietary supplementDaily oral supplementation with creatine monohydrate (3 g/day) and β-hydroxy-β-methylbutyrate (HMB, 3 g/day) for 12 weeks.
Change in Handgrip Strength
Change in maximal isometric handgrip strength measured in kilograms (kg) using a calibrated handheld dynamometer (best of three attempts for the dominant hand), expressed as the difference between baseline and 12 weeks.
Change in 6-Minute Walk Test Distance
Change in walking capacity assessed by the 6-minute walk test, measured as the difference in total distance walked (meters) between baseline and 12 weeks.
Change in Fat Mass
Change in total body fat mass measured in kilograms (kg) using multifrequency bioelectrical impedance analysis, expressed as the difference between baseline and 12 weeks.
Change in Skeletal Muscle Mass
Change in skeletal muscle mass measured in kilograms (kg) using multifrequency bioelectrical impedance analysis, expressed as the difference between baseline and 12 weeks.
Change in Fat-Free Mass
Change in fat-free mass measured in kilograms (kg) using multifrequency bioelectrical impedance analysis, expressed as the difference between baseline and 12 weeks.
Change in Phase Angle
Change in phase angle measured in degrees (°) using multifrequency bioelectrical impedance analysis, expressed as the difference between baseline and 12 weeks.
Change in Growth Differentiation Factor 15 (GDF-15)
Change in serum GDF-15 concentration (pg/mL) measured by immunoassay.
Change in Soluble ST2
Change in serum soluble ST2 concentration (ng/mL) measured by immunoassay.
Change in Interleukin-6 (IL-6)
Change in serum interleukin-6 (IL-6) concentration (pg/mL) measured by immunoassay.
Change in C-Reactive Protein (CRP)
Change in serum C-reactive protein (CRP) concentration (mg/L) measured by immunoassay.
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Universidad de Burgos
Lead sponsor
Hospital Universitario de Burgos
Collaborator
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