[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amyloidosis-transthyretin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amyloidosis-transthyretin":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100617103","attr-amyloid-cardiomyopathy-characterization-of-extracellular-vesicles-as-potential-disease-stratifiers-and-prognostic-biomarkers-100617103",false,"NCT07314268","ATTR Amyloid Cardiomyopathy: Characterization of Extracellular Vesicles as Potential Disease Stratifiers and Prognostic Biomarkers","EV-ATTR","Inclusion Criteria:\n\n* Adult patients aged 18 years or older;\n* Confirmed diagnosis of transthyretin cardiac amyloidosis (TTR-CA), with or without myocardial dysfunction, according to established diagnostic criteria;\n* Willingness to comply with study procedures and requirements;\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of other significant cardiac conditions that may interfere with study outcomes, such as severe coronary artery disease or major valvular disease;\n* Inability to provide informed consent or to participate in the required clinical assessments and examinations.",true,"ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","12 Months","OBSERVATIONAL","This study explores whether extracellular vesicles (EVs) tiny particles released into the bloodstream by cells can serve as early and minimally invasive biomarkers for transthyretin amyloid cardiomyopathy (ATTR-CM). Because ATTR-CM is often diagnosed only after significant heart damage has occurred, there is an urgent need for earlier detection methods.\n\nThe study will enroll individuals with different clinical presentations of transthyretin amyloidosis, along with healthy controls. Participants will undergo blood sampling, cardiac imaging (including echocardiography, cardiac MRI, and scintigraphy when indicated), and molecular EV analysis.\n\nBy comparing EV profiles across groups, the study aims to determine whether these vesicles reflect early cardiac involvement, track disease progression, and support more accurate and timely diagnosis. Ultimately, this research seeks to improve clinical decision-making and patient outcomes in ATTR cardiomyopathy.",[26,27,28,29],"Wild-type ATTR Amyloidosis","Amyloidosis Cardiac","Amyloidosis, Hereditary","Amyloidosis Transthyretin",[31,32,33,34,35],"Early Diagnosis","Serum Biomarkers","Transthyretin Amyloid Cardiomyopathy","ATTR","Vesicle Protein Signature","RECRUITING","2025-12-16",{"date":39,"type":40},"2026-01-02","ACTUAL",{"date":42,"type":40},"2024-10-18",{"date":44,"type":21},"2026-12-31",{"name":46,"class":47},"University of Sao Paulo General Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100403594","quantitative-analysis-of-myocardial-uptake-of-bone-radiopharmaceuticals-in-patients-with-cardiac-attr-amyloidosis-100403594","NCT04535349","Quantitative Analysis of Myocardial Uptake of Bone Radiopharmaceuticals in Patients With Cardiac ATTR Amyloidosis","Quantitative Analysis of Myocardial Uptake of 99mTclabeled Bone Radiopharmaceuticals Using New Whole-body CZT-based SPECT-CT Cameras, at Baseline and During Medical Treatment With Tafamidis in Patients With Cardiac Transthyretin Amyloidosis","REMOD-TTR","Inclusion Criteria:\n\n* Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures that required\u002Frequires treatment with a diuretic for improvement, and an increase of BNP \\>200 pg\u002FmL and\u002For NT-proBNP \\>500 pg\u002FmL\n* Suspected cardiac ATTR amyloidosis\n* Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness \\> 12 mm\n* Patient signed consent\n* Contraception method\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) functional class IV despite diuretic treatment\n* Life expectancy \\\u003C6 month due to the severity of cardiac amyloidosis and\u002For comorbidities\n* Aortic valve surgical or percutaneous replacement within 30 days or planned within months\n* Presence of primary (light chain) amyloidosis\n* Contraindication to tafamidis\n* Pregnancy and breast feeding ; pregnancy test in women of reproductive age irrespective of contraception method)\n* Adults with protective measures","100 Years",{"count":59,"type":21},35,"INTERVENTIONAL",[62],"NA","Introduction: Transthyretin cardiac amyloidosis (ATTR) is an important cause of heart failure. Cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is used as a noninvasive diagnostic criterion in patients without detectable monoclonal protein. The visual assessment remains the main noninvasive criterion for the diagnosis. Medical therapy using tafamidis meglumine that binds to transthyretin and prevents amyloidogenesis, recently demonstrated a reduction in all-cause mortality and cardiovascular-related hospitalizations. As a consequence, there is a need for quantitative approaches that would be useful for diagnosis and prognosis assessment but also for the evaluation of patient therapeutic response.\n\nMaterials and methods: The investigators aim to include 35 patients with a suspected diagnosis of cardiac ATTR amyloidosis in whom a cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is planned as part of routine noninvasive diagnosis work-up. Using a test-retest approach, the aim is to compare a quantitative method vs. conventional semi-quantitative approaches for the assessment of cardiac uptake of bone radiopharmaceuticals using new 3D CZT-based SPECT-CT cameras in patients with suspected cardiac ATTR amyloidosis. The investigators estimated that 20 patients will have a diagnosis of cardiac ATTR amyloidosis. In the latter patients, the aim is to evaluate the impact of 6-month therapy using tafamidis on quantitative and semi-quantitative assessment of cardiac uptake of bone radiopharmaceuticals Perspectives: This new non invasive imaging techniques for the quantitative assessment of the amyloid burden in patients with cardiac ATTR amyloidosis may help identify the responders and the patients who should benefit from dose intensification.",[29],"2025-01-29",{"date":67,"type":40},"2025-01-31",{"date":69,"type":40},"2020-10-08",{"date":71,"type":21},"2025-06-15",{"name":73,"class":47},"University Hospital, Caen"]