[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transthyretin-cardiac-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transthyretin-cardiac-amyloidosis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,72,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100635219","phase-2-exploratory-study-evaluating-the-relevance-of-68gaga-fapi-46-for-staging-and-identifying-progressing-patients-with-transthyretin-cardiac-amyloidosis-100635219",false,"NCT07549841","Exploratory Study Evaluating the Relevance of [68Ga]Ga-FAPI-46 for Staging and Identifying Progressing Patients With Transthyretin Cardiac Amyloidosis","FAPICAM","Inclusion Criteria:\n\n* Men or women ≥ 18 years\n* Definite ATTR-CM diagnosis based on the 2021 ESC expert consensus\n* Written and signed informed consent (obtained on the screening day at the latest and before any investigation)\n* Affiliation with French social security system or beneficiary from such system\n* Women must meet one of the following criteria at the time of inclusion:\n\n  * present a negative pregnancy test (blood test) before the injection of \\[68Ga\\]Ga-FAPI-46 and use highly1 effective contraceptive measures for a duration of 6 months after the PET with \\[68Ga\\]Ga-FAPI-46;\n  * or be post-menopausal (aged over 50 with amenorrhea for at least 12 months after stopping all exogenous hormone treatments);\n  * or (if under 50 years of age) have been in amenorrhea for at least 12 months after stopping exogenous hormone treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels corresponding to post-menopausal levels;\n  * or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented);\n* Male patients will be required to use male contraception (condoms) for a duration of 3 months after the PET;\n* Women partners will be required to use an acceptable2 contraceptive measure (as they will not receive the trial drug) for a duration of 3 months after the PET;\n* Male partners will be required to use male contraception (condoms) for a duration of 6 months after the PET.\n\nExclusion Criteria:\n\n* History of Myocardial infarction or myocarditis\n* Severe aortic stenosis\n* Current or prior participation in a clinical trial evaluating a TTR-targeted gene-silencing therapy (TTR= transthyretin) or an amyloid-depleting treatment for cardiac transthyretin amyloidosis (ATTR-CM).\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study and within 48 hours prior to PET for all female subjects of childbearing potential.\n* Patient under guardianship or trusteeship.\n* Patient under judicial protection.\n* Patient unable to understand spoken or written French\n* Known hypersensitivity to gallium-68, to any excipient or derivative","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Transthyretin cardiac amyloidosis (ATTR-CM) is an infiltrative cardiomyopathy caused by amyloid fibril deposition, leading to heart failure and arrhythmias. Despite advances in diagnosis, the disease remains commonly unrecognized and presents heterogeneously. Recent therapies targeting transthyretin stabilization and gene silencing have improved outcomes, but current staging systems based on biological and functional markers have limited ability to guide treatment.\n\nImaging techniques such as cardiac magnetic resonance (CMR) provide tissue characterization, but noninvasive molecular imaging of myocardial fibrotic activity remains limited. Positron emission tomography (PET) tracers targeting fibroblast activation protein (FAPI), labeled with gallium-68 (68Ga), offer a promising approach to detect and quantify fibroblast activity associated with myocardial remodeling.\n\nThis study aims to evaluate \\[68Ga\\]Ga-FAPI PET imaging for staging ATTR-CM and distinguishing patients with disease progression under therapy. The investigators hypothesize that \\[68Ga\\]Ga-FAPI uptake reflects fibrotic activity correlating with disease severity and progression. If validated, \\[68Ga\\]Ga-FAPI PET could serve as a novel biomarker for improved staging and personalized strategies in ATTR-CM.",[26],"Transthyretin Cardiac Amyloidosis",[28,29],"FAPI-46","staging and identifying progressing patients","NOT_YET_RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":20},"2026-09",{"date":38,"type":20},"2027-10",{"name":40,"class":41},"Nantes University Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100591302","multicenter-study-for-the-validation-of-an-ai-based-ecg-platform-for-early-cardiac-amyloidosis-diagnosis-100591302","NCT06978660","Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis","Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)","CONCERTO","Inclusion Criteria:\n\n* Subjects ≥ 18 years old\n* Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format\n\nExclusion Criteria:\n\n* Patients with paced rhythm on the ECG.",{"count":52,"type":20},2200,"OBSERVATIONAL","CONCERTO is a retrospective, observational, multicentric and single-arm study to perform an external validation of the cloud-based and AI-powered electrocardiogram (ECG) analysis platform, named Willem™, to detect Transthyretin cardiac amyloidosis (ATTR-CA). Thus, this study will assess Willem™ ability to distinguish between truly diagnosed ATTR-CA patients and confirmed non-ATTR-CA patients from ECG data.",[26],[57,58,59],"Transthyretin cardiac amyloidosis","ATTR","AI-based ECG Analysis","RECRUITING","2026-06-22",{"date":63,"type":34},"2026-06-23",{"date":65,"type":34},"2025-05-27",{"date":67,"type":20},"2026-12-31",{"name":69,"class":70},"Idoven 1903 S.L.","INDUSTRY",8,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100619390","eficac-ttr-trial-exercise-and-nutritional-supplementation-in-transthyretin-cardiac-amyloidosis-100619390","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.","70 Years",{"count":82,"type":20},102,[84],"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.",[26],[88,89,90,91,92,93,94,95,26],"Exercise Training","Nutritional Supplementation","Creatine","Beta-Hydroxy Beta-Methylbutyrate","Older Adults","Functional Capacity","Frailty","Cardiac Amyloidosis","2026-02-10",{"date":98,"type":34},"2026-02-11",{"date":100,"type":20},"2026-06",{"date":102,"type":20},"2027-09",{"name":104,"class":41},"Universidad de Burgos",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":42},"100500561","exercise-training-in-transthyretin-cardiac-amyloidosis-100500561","NCT05797857","Exercise Training in Transthyretin Cardiac Amyloidosis","Personalized Exercise Training to Improve Functional Capacity in Transthyretin Cardiac Amyloidosis","Inclusion Criteria:\n\n* Diagnosis and typing of ATTR-CM by endomyocardial biopsy or by Grade 2 or Grade 3 pyrophosphate (PYP) positivity (exception: nonamyloid control arm in aim 1).\n\n  * Diagnosis of heart failure, with prior or current need of diuretics and increased N-terminal prohormone B-natureitic peptide (BNP) (≥450 pg\u002Fml).\n  * Peak VO2 \\\u003C80% predicted, indicating impaired aerobic capacity (for aim 2 only).\n  * Taking tafamidis (for aim 2 only)\n  * Able to walk 4 meters (with or without the use of an assistive device) and independent with basic activities of daily living at the time of enrolment.\n  * Adequate clinical stability has been achieved in the judgment of the investigator to allow participation in study assessments and the intervention.\n  * Signed informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.\n\nExclusion Criteria:\n\n* Acute myocardial infarction (Note: given that cardiac biomarkers such as troponin are frequently elevated in ATTR-CM patients, the diagnosis of acute myocardial infarction should be based on clinical diagnosis, not biomarkers alone)\n\n  * \\>70% obstructive coronary artery disease\n  * Severe aortic valve stenosis\n  * Already actively participating in formal, facility-based cardiac exercise\n  * Already engaging in regular moderate to vigorous exercise conditioning defined as \\> 30 minutes per day, ≥ twice per week consistently during the previous 6 weeks\n  * Ventricular assist device\n  * Light chain amyloidosis or other form of non-ATTR amyloidosis\n  * Advanced chronic kidney disease defined as estimated glomerular filtration rate \\\u003C20 mL\u002Fmin\u002F1.73m2\n  * Any organ transplantation\n  * Terminal illness other than HF with life expectancy \\\u003C 1 year\n  * Pacemaker or implantable cardioverter-defibrillato (ICD) with heart rate limits \\\u003C expected heart rates for exercise and unable to be reprogrammed\n  * Neuropathy due to transthyretin (TTR) mutation\n  * Impairment from stroke, injury or other medical disorder that precludes participation in the intervention\n  * Abnormal cardiopulmonary exercise testing (CPET) finding that requires further investigation and management\n  * Dementia that precludes ability to participate in exercise and follow study protocols\n  * High risk for non-adherence as determined by screening evaluation\n  * Inability or unwillingness to comply with the study requirements","60 Years","90 Years",{"count":19,"type":20},[84],"Transthyretin cardiac amyloidosis causes debilitating heart failure in older adults. The proposed research will develop a personalized exercise training program to improve functional capacity in patients on optimal treatment for transthyretin cardiac amyloidosis. This is a vital next step to improve functional capacity and quality of life of people suffering from transthyretin cardiac amyloidosis.",[118,26],"Amyloid Cardiomyopathy","2025-03-14",{"date":121,"type":34},"2025-03-18",{"date":123,"type":34},"2024-07-10",{"date":125,"type":20},"2030-06-30",{"name":127,"class":41},"Brigham and Women's Hospital"]