[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538512":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":38,"collaborators":42,"id":46,"slug":10,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":10,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":10,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Aarhus University Hospital Skejby","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"wtATTR-CM patients (n = 100)",null,"Clinical history, physical examination, ECG, advanced echocardiography, blood and urine samples, cardiac magnetic resonance imaging (CMRI), and QoL questionaires (KCCQ, EQ-5Q-5L and ATTR-QoL)).\n\nSubgroup with these patient (n = 10): A endomyocardial biopsy.",{"label":13,"type":10,"description":14,"interventionNames":10},"Control (n = 20)","Blood and urine samples. To rule out cardiac disease: clinical history, physical examination, ECG and advanced echocardiography.",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Sie Kronborg Fensman, MD","CONTACT","+45 30 48 88 85","siefensman@gmail.com",[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Aarhus University Hospital","RECRUITING","Aarhus","Arrhus N","8200","Denmark",{"type":30,"coordinates":31},"Point",[32,33],10.21076,56.15674,{"lat":33,"lon":32},[36],{"name":37,"role":18,"phone":19,"phoneExt":10,"email":20},"Sie Kronborg Fensman",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Steen Hvitfeldt Poulsen","Professor, DMSc.",[43],{"name":44,"class":45},"Novo Nordisk A\u002FS","INDUSTRY","100538512",false,"NCT06291805","Phenotyping and Characterization of wtATTR-CM (TRACE 1)","Phenotyping and Characterization of Danish Wild-type Transthyretin Amyloidosis Cardiomyopathy Patients: A Cross-sectional Study","Group 1: wtATTR-CM patients\n\nInclusion Criteria:\n\n* Patients \\> 18 years diagnosed with ATTRwt-CM by:\n* endomyocardial biopsy\n* DPD scintigraphy with Perugini grade 2-3 where variant amyloidosis is ruled out due to genetic testing.\n* Informed oral and written consent\n\nExclusion Criteria:\n\n* AL amyloidosis (light-chain amyloidosis).\n* Myelomatosis\n* Waldenström macroglobulinemia\n\nGroup 2: Control group\n\nInclusion Criteria:\n\n* Patients \\> 18 years\n* Informed oral and written consent\n\nExclusion Criteria:\n\n* Known cardiovascular disease including ischemic heart disease, heart failure, atrial fibrillation, presence of a pacemaker, or malignant hypertension. Well-controlled hypertension is acceptable.\n* Suspicion of cardiac amyloidosis assessed through clinical history, physical examination, ECG, and echocardiography focusing on \"red flags\":\n* Echocardiography with:\n* Myocardial hypertrophy (septum \\>11 mm)\n* Apical sparing in LV-GLS\n* Infiltrative changes in the right ventricle free wall, thickened atrioventricular valves, or thickened atrial septum\n* Symptoms of polyneuropathy\n* Low voltage on ECG or discrepancy between left ventricular thickness and ECG amplitude indicative of low voltage\n* Atrioventricular block (AV block)\n* Bilateral carpal tunnel syndrome\n* Surgery for spinal stenosis\n* Elevated troponin I or NT-pro-BNP",true,"ALL","18 Years",{"count":56,"type":57},120,"ESTIMATED","OBSERVATIONAL","Descriptive cross-sectional study on 100 consecutive ATTRwt-CM patients reflecting all NAC stages aiming primarily to investigate ATTRwt-CM patient's quality of life (QoL) measures and their relation to ATTRwt-CM severity. Secondarily aiming to investigate the possibility to measure misTTR and fragTTR in plasma and urine and to detect fragTTR in endomyocardial biopsies from ATTRwt-CM patients. To investigate whether misTTR and fragTTR levels are correlated with ATTRwt-CM severity.",[61,62,63,64],"Transthyretin Amyloidosis","Transthyretin Amyloid Cardiomyopathy","Wild-Type Transthyretin-Related (ATTR)Amyloidosis","Quality of Life","2025-08-12",{"date":67,"type":68},"2025-08-15","ACTUAL",{"date":70,"type":68},"2024-02-20",{"date":72,"type":57},"2025-12",{"name":40,"class":6},1]