[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amyloidogenic-transthyretin-attr-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amyloidogenic-transthyretin-attr-amyloidosis":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100634348","pet-imaging-study-using-evuzamitide-to-detect-cardiac-amyloidosis-in-patients-with-inconclusive-nuclear-scans-and-elevated-tad1-levels-100634348",false,"NCT07538518","PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels","TAD1 Risk Assessment for Cardiac Amyloidosis With Evuzamitide (TRACE)","TRACE","Inclusion Criteria:\n\n1. Diagnosed as having heart failure or TTR variant allele carriers without symptoms of heart failure.\n2. Non-diagnostic nuclear scintigraphy for ATTR-CA (Perugini Grade 0 or 1).\n3. Elevated levels of Transthyretin Amyloid Detector-1 (TAD1).\n4. No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine.\n5. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.\n6. Able to understand and sign the informed consent document after the nature of the study has been fully explained.\n\nExclusion Criteria:\n\n1. Primary amyloidosis (AL) or secondary amyloidosis (AA).\n2. Ventricular assist device.\n3. Disabling dementia or other mental or behavioral disease.\n4. Enrollment in a clinical trial not approved for co-enrollment.\n5. Continuous intravenous inotropic therapy.\n6. Inability or unwillingness to comply with the study requirements.\n7. Chronic kidney disease requiring hemodialysis or peritoneal dialysis.\n8. Patients taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation.\n9. Other reason that would make the subject inappropriate for entry into this study.\n10. Pregnancy or current lactational feeding of infants.","ALL",{"count":19,"type":20},25,"ESTIMATED","OBSERVATIONAL","The goal of this study is to learn whether PET-CT imaging using evuzamitide can help diagnose transthyretin cardiac amyloidosis (ATTR-CA) in patients whose standard nuclear imaging results are unclear but who have elevated TAD1 levels in their blood. The main question it aims to answer is:\n\nCan evuzamitide PET-CT imaging detect signs of cardiac amyloidosis in patients with non-diagnostic nuclear scintigraphy but elevated TAD1 levels? Participants who meet eligibility criteria will receive a single PET-CT scan with evuzamitide and will be followed for approximately 28 days to monitor safety and collect additional clinical information.",[24,25],"Amyloidogenic Transthyretin (ATTR) Amyloidosis","Cardiac Amyloidosis",[27,28,29,30,31],"transthyretin","cardiac amyloidosis","TAD1","nuclear scintigraphy","Evuzamitide","NOT_YET_RECRUITING","2026-04-13",{"date":35,"type":36},"2026-04-20","ACTUAL",{"date":38,"type":20},"2026-06-01",{"date":40,"type":20},"2028-04-01",{"name":42,"class":43},"Lorena Saelices","OTHER",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":69,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100601897","phase-3-to-evaluate-the-long-term-safety-and-tolerability-of-acoramidis-in-participants-with-newly-diagnosed-attr-cm-act-early-ole-100601897","NCT07116473","To Evaluate the Long-term Safety and Tolerability of Acoramidis in Participants With Newly Diagnosed ATTR-CM (ACT-EARLY OLE)","A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients With Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy (ACT-EARLY OLE)","Key Inclusion Criteria:\n\nParticipants must have completed the AG10-501 study (ACT-EARLY study) within the past 60 calendar days with a diagnosis of ATTR-CM (based on the AG10-501 protocol definition of ATTR-CM).\n\nKey Exclusion Criteria:\n\n1. Participants who completed the AG10-501 study with a diagnosis of ATTR-PN only, or who permanently discontinued study drug prior to diagnosis of ATTR-CM in AG10-501.\n2. History of AL or another non-TTR amyloid subtype (eg, ApoA-1, gelsolin).\n3. History of a monoclonal paraprotein or abnormal light chains in serum or urine (i.e., MGUS) in which AL has not been ruled out.\n4. Stage IV or V chronic kidney disease (corresponding to an eGFR ≤ 29 mL\u002Fmin\u002F1.73 m2), or undergoing renal dialysis, or recipient of a kidney transplant.\n5. Active malignancy, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix that has been successfully treated. In the event a participant developed a low-grade and treatable malignancy in the AG10-501 study (eg, low-grade, localized prostate cancer) and the decision by the Investigator at that time was to continue the participant in the AG10-501 study, that participant may still qualify for Study AG10-504 after documentation with the Medical Monitor.\n6. History of any organ transplant (with the exception of corneal transplant).\n7. Known hypersensitivity to acoramidis or any of the excipients within the study drug.\n8. Treatment for ATTR-CM with any ATTR-oriented on- or off-label or OTC product.","18 Years",{"count":54,"type":20},250,"INTERVENTIONAL",[57],"PHASE3","The AG10-504 study is an open-label extension study of acoramidis in participants with newly diagnosed transthyretin amyloid cardiomyopathy (ATTR-CM) or both ATTR-CM and transthyretin amyloid polyneuropathy (ATTR-PN).",[60,61,62,63,24,64,65,66,67,68],"Amyloidosis in Transthyretin (TTR)","Amyloidosis, Familial","Amyloid Cardiomyopathy","Amyloid Cardiomyopathy, Transthyretin-Related","Heart Disease","Cardiomyopathies","Amyloidosis, Hereditary, Transthyretin-Related","Polyneuropathies","Amyloidosis",[70,71,68,72,73,74,75],"ATTR-CM","ATTR-PN","Transthyretin","Amyloid","TTR","Hereditary","2025-08-07",{"date":78,"type":36},"2025-08-11",{"date":80,"type":20},"2025-11",{"date":82,"type":20},"2037-12",{"name":84,"class":85},"Eidos Therapeutics, a BridgeBio company","INDUSTRY"]