[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"attr-cm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:attr-cm":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,70,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100619001","implementation-of-standardized-early-identification-and-diagnosis-for-transthyretin-amyloidosis-attr-in-high-risk-populations-100619001",false,"NCT07338942","Implementation of Standardized Early Identification and Diagnosis for Transthyretin Amyloidosis (ATTR) in High-Risk Populations","A Prospective, Multicenter, Intervention Study to Evaluate the Impact of the Implementation of Standardized Transthyretin Amyloidosis (ATTR) Early Identification and Diagnosis in ATTR High Risk Population","Inclusion Criteria:\n\n1. Age ≥ 60 years, at the time of signing the informed consent (ICF).\n2. Documented diagnosis of symptomatic heart failure (NYHA class I-III) at enrolment, and current diagnosis or a medical history of HF\n3. Documented Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\> 300 pg\u002FmL at enrolment.\n4. Documented LVEF ≥40% at enrolment.\n5. Documented LVH defined as end-diastolic wall thickness of ≥12 mm (IVS or PWT) on transthoracic Echocardiogram (TTE) at enrolment.\n6. Patients who are willing and able to comply with all scheduled visits, laboratory tests, and other study procedures.\n7. Willing and able to undergo 99mTc-PYP scintigraphy.\n8. Capable of giving signed ICF as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n1. Known etiology of myocardial disease: A confirmed diagnosis of amyloidosis (e.g., amyloid A amyloidosis, primary \\[light chain\\] amyloidosis), a non-amyloid infiltrative cardiomyopathy (i.e., cardiac sarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversible causes, hypertensive heart disease, pheochromocytoma, hypertrophic obstructive cardiomyopathy with known geneticetiology, or known pericardial constriction, etc. These diagnoses of myocardial disease could be further validated by the Investigator at Screening if the prior diagnosis is considered suspect.\n2. Known serum free light chain (sFLC), serum immunofixation electrophoresis (sIFE), or urine immunofixation electrophoresis (uIFE) anomalies.\n3. Prior clinical history of Coronary Artery Bypass Grafting (CABG) or multi-vessel obstructive coronary disease (\\>50% stenosis of \\>2 epicardial coronary arteries).\n4. Acute Myocardial Infarction (AMI) within 6 months before Screening.\n5. Unable to undergo 99mTc-PYP examination, such as:\n\n1)Previously documented hypersensitivity reaction to 99mTc; 2)Severe renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²); 3)Severe myelosuppression (leukocytes \\\u003C3.5×10⁹\u002FL or platelets \\\u003C80×10⁹\u002FL). 6.Other medical or psychiatric condition including recent (within the past year) active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the patient inappropriate for the study.","ALL","60 Years",{"count":19,"type":20},4000,"ESTIMATED","INTERVENTIONAL",[23],"NA","This multicenter, prospective, single-arm, interventional study will enroll about 4,000 adult patients at high risk of ATTR amyloidosis from around 50 sites in China. Eligible patients are aged ≥60 years and have documented symptomatic heart failure with left ventricular ejection fraction ≥40% and LVH. Exclusion criteria include known etiologies of myocardial diseases, anomalies of serum free light chain or serum immunofixation electrophoresis, acute myocardial infarction within 6 months before screening, and inability to undergo 99mTc-PYP. Patients will undergo a 14-week diagnostic process.\n\nThe study intervention involves knowledge training, operation training and post-training verification among investigators. Knowledge training for CV department investigators will cover disease-specific knowledge, standard diagnostic pathways, and genetics; training for investigators in echocardiology (ECHO) and nuclear medicine departments will focus on disease knowledge, standardized operating procedures (SOPs), and imaging parameter reporting. Operation training includes hands-on training in SOPs and image interpretation for ECHO and nuclear medicine investigators. Post-training verification will assess site-level compliance. Extra training will be arranged if quality audit is off target.\n\nThe primary endpoint is the proportion of patients diagnosed with ATTR amyloidosis in high-risk populations. Secondary endpoints include the proportion of patients with ATTRwt amyloidosis, concordance between local investigators and central reviewers in ECHO and 99mTc-PYP readings, and genotype distribution. All analyses will be descriptive with no pre-planned hypotheses. Risk factors associated with 99mTc-PYP-diagnosed ATTR amyloidosis will be analyzed via logistic regression models.",[26],"ATTR-CM","RECRUITING","2026-06-29",{"date":30,"type":31},"2026-06-30","ACTUAL",{"date":33,"type":31},"2026-04-21",{"date":35,"type":20},"2027-11-20",{"name":37,"class":38},"AstraZeneca","INDUSTRY",48,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100498896","quantitative-imaging-in-cardiac-transthyretin-amyloidosis-100498896","NCT05776212","Quantitative-imaging in Cardiac Transthyretin Amyloidosis","I-CARE","Inclusion Criteria:\n\n* Completion of informed consent\n* Age \\> 40 years for patients with ATTR or AL cardiac amyloidosis and age \\>30 years for patients with HCM\n* ATTR cardiac amyloid according to Expert Consensus Recommendations\n* AL amyloidosis according to Expert Consensus Recommendations\n* Hypertrophic cardiomyopathy according to European Society of Cardiology guidelines\n\nExclusion Criteria:\n\n* Inability or unwilling to give informed consent\n* Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial.\n* Renal dysfunction (eGFR ≤30 mL\u002Fmin\u002F1.73m2)\n* NYHA Class IV heart failure\n* Patients with atrial fibrillation and poor rate control.\n* Contraindications to MR\n* Previous history of contrast allergy of adverse reactions (gadolinium)\n* Contraindications to tafamidis therapy","40 Years",{"count":49,"type":20},140,"OBSERVATIONAL","Transthyretin amyloid cardiomyopathy (ATTR-CM), is a heart muscle disease that's stops the heart muscle working properly. With an ageing population, it is increasingly common but untreated, it has a poor prognosis. Several novel expensive treatments have become available, although we do not understand exactly how they work and why some patients respond, and others do not. The challenge is to develop better methods for monitoring the effects of these treatments, maximizing their benefits and cost-effectiveness. In I-CARE we aim to bring a new imaging technique, named 18F-fluoride PET, to the clinic and thereby improve the care of patients with ATTR-CM.\n\nHypotheses:\n\n1. A delayed imaging protocol and state-of-the-art PET motion correction will optimise 18F-fluoride imaging in ATTR-CM and provide a clear threshold in myocardial TBR values for the diagnosis of ATTR-CM.\n2. Optimised 18F-fluoride PET will provide a quantitative marker of the ATTR-CM burden that will allow disease progression and treatment response to be tracked.\n3. Myocardial 18F-fluoride TBR values will reduce in patients responding to tafamidis treatment and increase in non-responders and patients not receiving therapy",[26],[54,55,56,57,58],"Amyloidosis","Heart failure","18F-fluoride positron emission tomography (PET)","Cardiovascular magnetic resonance (CMR)","Tafamidis","2026-06-23",{"date":61,"type":31},"2026-06-26",{"date":63,"type":31},"2021-08-25",{"date":65,"type":20},"2026-09-30",{"name":67,"class":68},"University of Edinburgh","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100551878","non-interventional-study-of-patients-with-transthyretin-attr-amyloidosis-100551878","NCT06465810","Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis","A Non-interventional, Prospective, Multi-country Study Collecting Real-world Data on the Characteristics, Treatment Patterns, and Outcomes of Patients With Transthyretin (ATTR) Amyloidosis","MaesTTRo","Inclusion Criteria:\n\n* Patient willing and able to provide written informed consent to participate in the study\n* Confirmed diagnosis of amyloid transthyretin (ATTR) amyloidosis\n* Aged ≥18 years at the time of signing the informed consent\n* Patient willing and able to participate in collection of electronic patient reported outcomes (PROs)\n\nExclusion Criteria:\n\n* Concurrent participation in any interventional trial for ATTR amyloidosis\n* Involvement in the planning and\u002For conduct of the current study\n* Patients with evidence of primary or light chain amyloidosis (AL) or serum protein A amyloidosis (AA)\n* Asymptomatic patients with ATTR amyloidosis and asymptomatic ATTR mutation carriers","18 Years","130 Years",{"count":81,"type":20},1850,"The MaesTTRo study aims to enroll a global cohort of patients with transthyretin (ATTR) amyloidosis to longitudinally observe the natural course of the disease and describe real-world treatment patterns and outcomes. In addition, information on the effectiveness of ATTR amyloidosis treatments, including eplontersen, which is a ligand-conjugated antisense oligonucleotide gene silencing treatment targeting activity against both the mutant and wild-type TTR protein, will be collected.",[84,26,85,86,87,88],"Transthyretin Amyloidosis","ATTRv-PN","ATTR","ATTR-Mixed","hATTR",[54,90,91,92,93,94,95,96,97,98,99,86,100,101,102,103,104,105,106,107,108,109],"Transthyretin","Hereditary transthyretin-mediated (hATTR) amyloidosis","hATTR amyloidosis","Hereditary ATTR amyloidosis","Wild-type amyloidosis","wtATTR amyloidosis","ATTRv amyloidosis","ATTRwt amyloidosis","Polyneuropathy","Familial amyloid polyneuropathies","Transthyretin amyloidosis","TTR-mediated amyloidosis","Polyneuropathies","Amyloid neuropathies","Amyloid neuropathies, familial","Amyloidosis, familial","Eplontersen","Non-interventional","Observational","Real-world","2026-06-19",{"date":59,"type":31},{"date":113,"type":31},"2024-06-25",{"date":115,"type":20},"2031-12-29",{"name":37,"class":38},74,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100580339","a-multicenter-study-on-atrioventricular-regurgitation-in-transthyretin-amyloid-cardiomyopathy-definition-prevalence-and-prognostic-impact-100580339","NCT06836011","A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.","Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study","Inclusion Criteria:\n\n* Diagnosis of ATTR-CM according to current diagnostic criteria\n* Comprehensive baseline echocardiographic assessment, including (semi-)quantitative mitral and tricuspid regurgitation (MR\u002FTR) parameters, performed within ±6 months of diagnosis\n* Age ≥ 18 years\n* Willingness to participate in the study and provide informed consent\n\nExclusion Criteria:\n\n* Severe aortic valve disease requiring intervention\n* Inability to provide informed consent or participate in study follow-up",{"count":126,"type":20},600,"The objective of this prospective registry study is to comprehensively characterize the prevalence, (semi-) quantitative parameters, and associated clinical outcomes of mitral (MR) and tricuspid regurgitation (TR) in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). The study further aims to develop and implement new grading standards for the quantitative assessment of regurgitation severity, tailored to the distinct hemodynamic profile of ATTR-CM. This approach seeks to address the limitations of current regurgitation severity classifications, which do not adequately reflect the unique pathophysiology of a restrictive phenotype as seen in ATTR-CM.",[129,26,130,131,132],"ATTR Amyloidosis With Cardiomyopathy","ATTR Amyloidosis Wild Type","Mitral Regurgitation","Tricuspid Regurgitation",[26,134,132,131],"ATTR amyloidosis","2025-02-14",{"date":137,"type":31},"2025-02-19",{"date":139,"type":31},"2025-01-01",{"date":141,"type":20},"2026-12-31",{"name":143,"class":68},"Medical University of Vienna",8]