NCT07343999Completed
EFICAC-TTR Trial: Exercise and Nutritional Supplementation in Transthyretin Cardiac Amyloidosis
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 17 Dec 2025
- Start date
- 3 Feb 2026
- Primary completion date
- 10 Sept 2026
- Lead sponsor
- Universidad de Burgos
- Diseases
- Amyloidosis
- NCT number
- NCT07343999
What you commit to
- Study type: Interventional
- Participants enrolled: 47
- From 3 Feb 2026 to the primary completion date, 10 Sept 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another clinical trial or structured exercise program.
Other illness
- Severe comorbid conditions with an estimated life expectancy \<6 months.
- Severe cognitive impairment (Mini-Mental State Examination score \<20).
- Known allergy or intolerance to creatine, beta-hydroxy-beta-methylbutyrate (HMB), or microcrystalline cellulose.
- Severe renal impairment requiring dialysis.
Other
- Light-chain (AL) amyloidosis or other non-TTR amyloidosis variants.
- Absolute medical contraindication to moderate-intensity exercise.
Who the study is looking for
- 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.
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Santos Reyes Coordinator of this site? Confirm its status | Aranda de Duero | Spain | Unknown status |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Unknown status |
| Hospital Santa Bárbara Coordinator of this site? Confirm its status | Soria | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.