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

Universidad de Burgos

Status: Not yet enrolling

Conditions: Transthyretin Cardiac Amyloidosis

Treatments: Other: Usual Care; Behavioral: Home-Based Multicomponent Exercise Program; Dietary Supplement: Fiber Supplementation (Microcrystalline Cellulose); Dietary Supplement: Creatine and HMB Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT07343999

EFICAC-TTR-UBU-HUBU

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 3 patient groups, including a placebo group

Usual Care

Other group

Description:

Participants receive usual medical care for transthyretin cardiac amyloidosis, including routine cardiology follow-up and general lifestyle recommendations, without structured exercise or nutritional supplementation.

Treatment:

Other: Usual Care

Exercise + Fiber Supplementation (Active Control)

Placebo Comparator group

Description:

Participants perform a home-based multicomponent exercise program and receive daily supplementation with microcrystalline cellulose, used as a nutritionally inert control supplement.

Treatment:

Dietary Supplement: Fiber Supplementation (Microcrystalline Cellulose)

Behavioral: Home-Based Multicomponent Exercise Program

Exercise + Creatine and HMB Supplementation

Experimental group

Description:

Participants perform a home-based multicomponent exercise program and receive daily supplementation with creatine monohydrate (3 g/day) and β-hydroxy-β-methylbutyrate (HMB, 3 g/day).

Treatment:

Dietary Supplement: Creatine and HMB Supplementation

Behavioral: Home-Based Multicomponent Exercise Program