[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transthyretin-ttr-amyloid-cardiomyopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transthyretin-ttr-amyloid-cardiomyopathy":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100651831","liver-and-coagulation-disorders-in-cardiac-transthyretin-amyloidosis-100651831",false,"NCT07766135","Liver and Coagulation Disorders in Cardiac Transthyretin Amyloidosis","Liver and Coagulation Disorders in Cardiac Transthyretin Amyloidosis (ATTR-CA): New Horizons in Disease Staging and Follow-Up","LICA2025","Inclusion Criteria:\n\n* Written informed consent obtained prior to study participation.\n* Diagnosis of wild-type or hereditary transthyretin cardiac amyloidosis (ATTR-CA) according to current European recommendations.\n* Ability to comply with study procedures and follow-up visits.\n\nExclusion Criteria:\n\n* Age younger than 18 years.\n* Severe liver dysfunction due to causes other than amyloidosis.\n* Inability to comply with study procedures because of language barriers, cognitive impairment, or severe psychiatric disorders.\n* Comorbidities associated with life expectancy less than 12 months.\n* Active alcohol or substance abuse.\n* For coagulation analyses: congenital coagulation disorders, thrombotic disorders, active malignancy, or sepsis.\n* Pregnancy or breastfeeding.","ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","OBSERVATIONAL","Transthyretin cardiac amyloidosis (ATTR-CA) is a progressive infiltrative cardiomyopathy caused by the deposition of misfolded transthyretin protein within the myocardium. Current disease staging and follow-up strategies mainly rely on cardiac biomarkers and renal function; however, the systemic nature of ATTR suggests that additional organ involvement may provide valuable prognostic information.\n\nThe purpose of this prospective observational study is to investigate liver dysfunction and coagulation abnormalities in patients with wild-type or hereditary ATTR-CA and to evaluate their potential role as novel markers of disease severity and progression. Patients with ATTR-CA will be compared with an age-matched control population with non-amyloid hypertrophic cardiomyopathy.\n\nClinical, laboratory, echocardiographic, hepatic ultrasound, liver stiffness, and coagulation parameters will be assessed at baseline and during follow-up. The study will also evaluate changes in these parameters after 6 and 12 months of treatment with tafamidis.\n\nThe results may improve the understanding of cardio-hepatic interactions in ATTR-CA and identify new tools for disease staging and longitudinal monitoring.",[25,26,27,28,29],"Transthyretin (TTR) Amyloid Cardiomyopathy","Cardiac Amyloidosis","Cardiomyopathies","Wild-Type Transthyretin Cardiac Amyloidosis","Hereditary Transthyretin Amyloidosis (ATTRv)",[31,32,26,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"ATTR","ATTR-CA","Transthyretin Amyloidosis","Tafamidis","Acoramidis","Liver Stiffness","Fibroscan","Liver Dysfunction","Hepatic Congestion","Coagulation Disorder","Hemostasis","Cardiohepatic Syndrome","Biomarkers","Disease Staging","Echocardiography","Heart Failure","Wild-Type ATTR","Hereditary ATTR","RECRUITING","2026-08-10",{"date":52,"type":53},"2026-08-14","ACTUAL",{"date":55,"type":53},"2026-01-30",{"date":57,"type":21},"2028-01",{"name":59,"class":60},"University of Messina","OTHER",1,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":72,"conditions":73,"keywords":74,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":61},"100608075","determining-the-association-of-ttr-stabilizing-therapy-with-circulating-ttr-amyloid-aggregates-over-time-in-patients-with-attr-cm-longitudinal-biomarker-study-100608075","NCT07196839","Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study","Inclusion Criteria:\n\n* Men and women ages 30-80 who have symptomatic ATTR-CA as determined by a history of HF (this will be assessed by study personnel and defined as : 1) history of hospitalization within the previous 12 months for management of HF; 2) an elevated B-type natriuretic peptide level ≥100 pg\u002FmL or NT-proBNP ≥360 pg\u002FmL within the previous 12 months; or 3) a clinical diagnosis of HF from a treating clinician)\n* ATTR-CA previously diagnosed histologically by amyloid staining and tissue typing with immunohistochemistry or mass spectrometry or by bone scintigraphy in without abnormal M-protein\n* TTR gene sequencing confirming the TTR genotype has resulted or is pending\n* Enrollment will be stratified by n\u002FN=30\u002F50 starting on-label TTR-stabilizing therapy (e.g. tafamidis) within 5 days after enrollment or by n\u002FN=20\u002F50 of those currently taking TTR-stabilizing therapy\n\nExclusion Criteria:\n\n* Other known causes of cardiomyopathy\n* History of light-chain cardiac amyloidosis\n* Cardiac transplantation\n* Liver transplantation\n* Has taken patisiran in the past 90 days, or inotersen in the past 180 days, has ever taken vutrisiran, or is participating in a clinical trial for ATTR treatments\n* Estimated glomerular filtration rate ≤30 mL\u002Fmin\u002F1.73 m2\n* Anticipated gaps in ATTR-CA treatment for 3 months after enrollment","30 Years","80 Years",{"count":71,"type":21},50,"The objective of this study is to determine the association of clinically prescribed, on-label, TTR stabilizing therapy (e.g. tafamidis or acoramidis) with levels of circulating transthyretin amyloid aggregates (TAAs, a surrogate for amyloid disease activity) measured serially over time in patients with transthyretin cardiac amyloidosis (ATTR-CA). To accomplish this objective, the hypothesis that TTR stabilizing therapy will be associated lower circulating TAAs over time will be tested. Completion of this study will advance the understanding of the influence of ATTR-CA treatments on circulating evidence of amyloidosis and justify the role of blood testing to monitor treatment response in patients with ATTR-CA.",[25],[75,76,77,78],"transthyretin","tafamidis","acoramidis","amyloidosis","2026-01-06",{"date":81,"type":53},"2026-01-07",{"date":83,"type":53},"2025-12-31",{"date":85,"type":21},"2027-03",{"name":87,"class":60},"University of Texas Southwestern Medical Center"]