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Transthyretin Cardiac AmyloidosisEFICAC-TTRNCT07343999

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

A study testing Home-Based Multicomponent Exercise Program and Creatine and HMB Supplementation in people with Transthyretin Cardiac Amyloidosis, run by Universidad de Burgos at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Transthyretin Cardiac Amyloidosis
What is being tested?
Home-Based Multicomponent Exercise Program and Creatine and HMB Supplementation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
3 sitesSpain
Study dates
3 Feb 2026to 10 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital Santos Reyes

    Aranda de Duero, Castille and León

  • Hospital Universitario de Burgos

    Burgos, Castille and León, 09006

  • Hospital Santa Bárbara

    Soria, Castille and León

Other trials in Spain

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

Participants were randomized to three parallel study groups. The usual-care group continued standard clinical management without a structured exercise program or study supplementation. Participants in the two exercise groups performed the same 12-week home-based multicomponent exercise program adapted to individual functional capacity.

In addition to exercise, one group received daily microcrystalline cellulose as a control supplement, whereas the experimental group received creatine monohydrate (3 g/day) plus beta-hydroxy-beta-methylbutyrate (HMB, 3 g/day). The supplement comparison was blinded, while the comparison with usual care was necessarily open because of the behavioral intervention. Functional outcomes were assessed at baseline and after 12 weeks.

Biological samples collected at baseline and after the intervention are used for exploratory mechanistic analyses.

Being tested
Home-Based Multicomponent Exercise Program, Microcrystalline Cellulose Control Supplementation, Creatine and HMB Supplementation, Usual Care
Keywords
Exercise Training, Nutritional Supplementation, Creatine, Beta-Hydroxy Beta-Methylbutyrate, Older Adults, Functional Capacity, Frailty, Cardiac Amyloidosis, Transthyretin Cardiac Amyloidosis
Medical subject headings
Frailty, Amyloid Neuropathies, Familial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-Based Multicomponent Exercise ProgramBehavioural

    A 12-week home-based multicomponent exercise program adapted from the Vivifrail model, including strength, balance, mobility, and endurance exercises tailored to individual functional capacity.

  • Microcrystalline Cellulose Control SupplementationDietary supplement

    Daily oral supplementation with microcrystalline cellulose, used as a nutritionally inert control supplement to match supplementation procedures.

  • Creatine and HMB SupplementationDietary supplement

    Daily oral supplementation with creatine monohydrate (3 g/day) and β-hydroxy-β-methylbutyrate (HMB, 3 g/day) for 12 weeks.

  • Usual CareOther

    Standard clinical management for transthyretin cardiac amyloidosis according to routine cardiology practice.

Study groups in NCT07343999
Study groupRoleWhat they receive
Usual CareOtherParticipants received usual medical care for transthyretin cardiac amyloidosis, including routine cardiology follow-up and general lifestyle and nutritional recommendations, without the structured study exercise program or study supplementation.
Receives: Other: Usual Care
Exercise + Microcrystalline Cellulose Control SupplementationPlacebo comparatorParticipants performed a 12-week home-based multicomponent exercise program and received daily microcrystalline cellulose as the control supplement. The supplement was provided in sachets matched to the supplementation procedure used in the experimental arm.
Receives: Behavioral: Home-Based Multicomponent Exercise Program; Dietary Supplement: Microcrystalline Cellulose Control Supplementation
Exercise + Creatine and HMB SupplementationExperimentalParticipants performed the same 12-week home-based multicomponent exercise program and received daily supplementation with creatine monohydrate (3 g/day) and beta-hydroxy-beta-methylbutyrate (HMB, 3 g/day).
Receives: Behavioral: Home-Based Multicomponent Exercise Program; Dietary Supplement: Creatine and HMB Supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 12 weeks

  2. 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.

    Measured: Baseline and 12 weeks

Secondary outcomes (17)

  1. 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.

    Measured: Baseline and 12 weeks

  2. 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.

    Measured: Baseline and 12 weeks

  3. 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.

    Measured: Baseline and 12 weeks

  4. 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.

    Measured: Baseline and 12 weeks

  5. Change in Frailty Status Assessed by the FRAIL Scale

    Change in frailty status assessed by the FRAIL scale, a 5-item questionnaire with scores ranging from 0 to 5, where higher scores indicate greater frailty, expressed as the difference between baseline and 12 weeks.

    Measured: Baseline and 12 weeks

  6. Change in Short Physical Performance Battery (SPPB) Score

    Change in Short Physical Performance Battery (SPPB) total score, ranging from 0 to 12 points, where higher scores indicate better physical performance, expressed as the difference between baseline and 12 weeks.

    Measured: Baseline and 12 weeks

  7. Change in Clinical Frailty Scale (CFS) Score

    Change in frailty severity assessed by the Clinical Frailty Scale (CFS), a 9-point ordinal scale ranging from 1 (very fit) to 9 (terminally ill), where higher scores indicate greater frailty.

    Measured: Baseline and 12 weeks

  8. Change in Barthel Index Score

    Change in functional independence assessed by the Barthel Index, scored from 0 to 100, where higher scores indicate greater independence.

    Measured: Baseline and 12 weeks

  9. Change in SARC-F Score

    Change in sarcopenia risk assessed by the SARC-F questionnaire, with scores ranging from 0 to 10, where higher scores indicate greater sarcopenia risk.

    Measured: Baseline and 12 weeks

  10. Change in Minnesota Living With Heart Failure Questionnaire Score

    Change in health-related quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLHFQ), with total scores ranging from 0 to 105, where higher scores indicate worse quality of life.

    Measured: Baseline and 12 weeks

  11. Change in Charlson Comorbidity Index

    Change in comorbidity burden assessed using the Charlson Comorbidity Index, a weighted index that accounts for the number and severity of comorbid conditions, where higher scores indicate greater comorbidity burden.

    Measured: Baseline and 12 weeks

  12. Exercise Program Adherence

    Proportion (%) of prescribed exercise sessions completed, with adequate adherence defined as completion of at least 80% of prescribed sessions.

    Measured: Up to 12 weeks

  13. Supplement Adherence

    Proportion (%) of planned supplement doses consumed, with optimal compliance defined as 90-110%.

    Measured: Up to 12 weeks

  14. Change in Mini Nutritional Assessment Short-Form (MNA-SF) Score

    Change in nutritional status assessed by the Mini Nutritional Assessment Short-Form (MNA-SF), with scores ranging from 0 to 14 points, where lower scores indicate poorer nutritional status and greater risk of malnutrition.

    Measured: Baseline and 12 weeks

  15. Incidence of Intervention-Related Adverse Events

    Number and type of adverse events related to exercise and/or supplementation, classified according to severity and relatedness, collected during the 12-week intervention period.

    Measured: Up to 12 weeks

  16. Rate of Supplement Discontinuation

    Proportion of participants who discontinue study supplementation during the intervention period.

    Measured: Up to 12 weeks

  17. Change in Skeletal Muscle Index (SMI)

    Change in skeletal muscle index (SMI), expressed as skeletal muscle mass normalized to height squared (kg/m²), measured using multifrequency bioelectrical impedance analysis, between baseline and 12 weeks.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start3 Feb 2026
  3. Primary completion10 Sep 2026
  4. Study completion10 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned to one of three parallel groups: usual care, home-based multicomponent exercise plus microcrystalline cellulose control supplementation, or the same exercise program plus creatine and HMB supplementation. Participants remained in their assigned group throughout the 12-week intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07343999
Sponsor's protocol ID
EFICAC-TTR-UBU-HUBU
Acronym
EFICAC-TTR
Status last verified
Sep 2026
First submitted
17 Dec 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported in publications will be made available upon reasonable request.

Publications

  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

    PubMed 31081853

  • Ramos-Hernandez R, Miguel-Ortega A, Martinez-Ferran M, Fernandez-Lazaro D, Busto N, Mielgo-Ayuso J. Combined creatine and HMB co-supplementation improves functional strength independent of muscle mass in physically active older adults: a randomized crossover trial. Geroscience. 2026 Jun;48(3):4457-4475. doi: 10.1007/s11357-025-01889-y. Epub 2025 Oct 10.

    PubMed 41073834

  • de Souto Barreto P, Rolland Y, Vellas B, Maltais M. Association of Long-term Exercise Training With Risk of Falls, Fractures, Hospitalizations, and Mortality in Older Adults: A Systematic Review and Meta-analysis. JAMA Intern Med. 2019 Mar 1;179(3):394-405. doi: 10.1001/jamainternmed.2018.5406.

    PubMed 30592475

  • Garcia-Pavia P, Rapezzi C, Adler Y, Arad M, Basso C, Brucato A, Burazor I, Caforio ALP, Damy T, Eriksson U, Fontana M, Gillmore JD, Gonzalez-Lopez E, Grogan M, Heymans S, Imazio M, Kindermann I, Kristen AV, Maurer MS, Merlini G, Pantazis A, Pankuweit S, Rigopoulos AG, Linhart A. Diagnosis and treatment of cardiac amyloidosis: a position statement of the ESC Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2021 Apr 21;42(16):1554-1568. doi: 10.1093/eurheartj/ehab072.

    PubMed 33825853

  • Ruberg FL, Grogan M, Hanna M, Kelly JW, Maurer MS. Transthyretin Amyloid Cardiomyopathy: JACC State-of-the-Art Review. J Am Coll Cardiol. 2019 Jun 11;73(22):2872-2891. doi: 10.1016/j.jacc.2019.04.003.

    PubMed 31171094

Questions about this trial

What is this clinical trial studying?

A study testing Home-Based Multicomponent Exercise Program and Creatine and HMB Supplementation in people with Transthyretin Cardiac Amyloidosis, run by Universidad de Burgos at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Handgrip Strength (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07343999, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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