[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619390":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":45,"centralContacts":53,"locations":30,"responsibleParty":61,"collaborators":63,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":30,"enrollmentInfo":75,"targetDuration":30,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":93,"whyStopped":30,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":30},{"fullName":5,"class":6},"Universidad de Burgos","OTHER",[8,13,20],{"label":9,"type":6,"description":10,"interventionNames":11},"Usual Care","Participants receive usual medical care for transthyretin cardiac amyloidosis, including routine cardiology follow-up and general lifestyle recommendations, without structured exercise or nutritional supplementation.",[12],"Other: Usual Care",{"label":14,"type":15,"description":16,"interventionNames":17},"Exercise + Fiber Supplementation (Active Control)","PLACEBO_COMPARATOR","Participants perform a home-based multicomponent exercise program and receive daily supplementation with microcrystalline cellulose, used as a nutritionally inert control supplement.",[18,19],"Behavioral: Home-Based Multicomponent Exercise Program","Dietary Supplement: Fiber Supplementation (Microcrystalline Cellulose)",{"label":21,"type":22,"description":23,"interventionNames":24},"Exercise + Creatine and HMB Supplementation","EXPERIMENTAL","Participants perform a home-based multicomponent exercise program and receive daily supplementation with creatine monohydrate (3 g\u002Fday) and β-hydroxy-β-methylbutyrate (HMB, 3 g\u002Fday).",[18,25],"Dietary Supplement: Creatine and HMB Supplementation",[27,31,36,41],{"type":6,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"Standard clinical management for transthyretin cardiac amyloidosis according to routine cardiology practice.",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"BEHAVIORAL","Home-Based Multicomponent Exercise Program","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.",[21,14],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":30},"DIETARY_SUPPLEMENT","Fiber Supplementation (Microcrystalline Cellulose)","Daily oral supplementation with microcrystalline cellulose, used as a nutritionally inert control supplement to match supplementation procedures.",[14],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":30},"Creatine and HMB Supplementation","Daily oral supplementation with creatine monohydrate (3 g\u002Fday) and β-hydroxy-β-methylbutyrate (HMB, 3 g\u002Fday) for 12 weeks.",[21],[46,49],{"name":47,"affiliation":5,"role":48},"Juan Mielgo-Ayuso, PhD","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":51,"role":52},"José A Pérez Rivera, PhD, MD","Hospital Universitario de Burgos","STUDY_CHAIR",[54,58],{"name":47,"role":55,"phone":56,"phoneExt":30,"email":57},"CONTACT","+34 947 25 87 00","jmielgo@ubu.es",{"name":50,"role":55,"phone":59,"phoneExt":30,"email":60},"+34 947 28 19 64","jangel.perezrivera@gmail.com",{"type":62,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[64],{"name":51,"class":6},"100619390","eficac-ttr-trial-exercise-and-nutritional-supplementation-in-transthyretin-cardiac-amyloidosis-100619390",false,"NCT07343999","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","EFICAC-TTR","Inclusion Criteria:\n\n* Age ≥70 years.\n* 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.\n* Clinical stability during the 4 weeks prior to enrollment.\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Light-chain (AL) amyloidosis or other non-TTR amyloidosis variants.\n* Absolute medical contraindication to moderate-intensity exercise.\n* Severe comorbid conditions with an estimated life expectancy \\\u003C6 months.\n* Severe cognitive impairment (Mini-Mental State Examination score \\\u003C20).\n* Concurrent participation in another clinical trial or structured exercise program.\n* Known allergy or intolerance to creatine, beta-hydroxy-beta-methylbutyrate (HMB), or microcrystalline cellulose.\n* Severe renal impairment requiring dialysis.","ALL","70 Years",{"count":76,"type":77},102,"ESTIMATED","INTERVENTIONAL",[80],"NA","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.\n\nThe 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.\n\nA 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.\n\nThe 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.\n\nThis 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.",[83],"Transthyretin Cardiac Amyloidosis",[85,86,87,88,89,90,91,92,83],"Exercise Training","Nutritional Supplementation","Creatine","Beta-Hydroxy Beta-Methylbutyrate","Older Adults","Functional Capacity","Frailty","Cardiac Amyloidosis","NOT_YET_RECRUITING","2026-02-10",{"date":96,"type":97},"2026-02-11","ACTUAL",{"date":99,"type":77},"2026-06",{"date":101,"type":77},"2027-09",{"name":5,"class":6}]