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

Starting soon · Not applicable

Conditions studied: Transthyretin Cardiac Amyloidosis

In brief

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.

Key facts

Study ID

NCT07343999

Run by

Universidad de Burgos

People needed

102

Starts

2026-06-01

Expected to finish

2027-09-01

Last updated by the study team

2026-02-11

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).
• Concurrent participation in another clinical trial or structured exercise program.
• Known allergy or intolerance to creatine, beta-hydroxy-beta-methylbutyrate (HMB), or microcrystalline cellulose.
• Severe renal impairment requiring dialysis.

Full record on ClinicalTrials.gov

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