[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550376":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":31,"locations":40,"responsibleParty":61,"collaborators":63,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":10,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":10,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"NHS Greater Glasgow and Clyde","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gene positive participants (personal history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant)",null,"Pathogenic and likely pathogenic variants defined by American College of Medical Genetics guidelines.\n\nExpected recruitment of: 300 TTN, 300 MYBPC3, up to 50 LMNA, up to 50 FLNC and up to 50 DSP",[13],"Diagnostic Test: Plasma biomarker levels",{"label":15,"type":10,"description":16,"interventionNames":17},"Gene negative controls (family history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant)","Expected recruitment of 50 patients.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Plasma biomarker levels","This study will investigate existing and novel biomarkers (including blood, urine electrocardiographic and imaging) at various stages of disease in patients with a personal or family history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant, which are known to cause cardiomyopathy.\n\nCardiomyopathy will be defined per European Society of Cardiology cardiomyopathy guidelines and heart failure stage will be defined per American Heart Associate guidelines.",[15,9],[25,26,27,28,29,30],"Electrocardiogram","Echocardiogram","Cardiac magnetic resonance imaging","24-hour Holter monitor","Questionnaires (Kansas City Cardiomyopathy Questionnaire & General Practice Physical Activity Questionnaire)","Urine biomarker levels",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Caroline J Coats, MBBS, PhD","CONTACT","0141 451 6121","Caroline.Coats@glasgow.ac.uk",{"name":38,"role":34,"phone":35,"phoneExt":10,"email":39},"Rachel C Myles, MBBS, PhD","Rachel.Myles@glasgow.ac.uk",[41],{"facility":42,"status":43,"city":44,"state":10,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Queen Elizabeth University Hospital","RECRUITING","Glasgow","G51 4TF","United Kingdom","UK",{"type":49,"coordinates":50},"Point",[51,52],-4.25763,55.86515,{"lat":52,"lon":51},[55,56,59],{"name":33,"role":34,"phone":10,"phoneExt":10,"email":36},{"name":57,"role":34,"phone":10,"phoneExt":10,"email":58},"Fraser C Goldie, MBChB","Fraser.Goldie@glasgow.ac.uk",{"name":33,"role":60,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[64,66],{"name":65,"class":6},"University of Glasgow",{"name":67,"class":68},"Roche Diagnostics GmbH","INDUSTRY","100550376","biomarkers-in-scotland-cardiomyopathy-registry-bio-scotch-100550376",false,"NCT06446271","Biomarkers in SCOTland CardiomyopatHy Registry (Bio-SCOTCH)","Biomarkers in SCOTland CardiomyopatHy Registry","Inclusion Criteria:\n\n* Male or female ≥10 years of age\n* Written informed consent \u002F assent\n* Pathogenic or likely pathogenic variant in a cardiomyopathy gene (TTN, LMNA, MYBPC3, DSP, FLNC) or undergoing predictive genetic testing (if negative these people would be invited to enter the control arm)\n\nExclusion Criteria:\n\n* Unable to consent.\n* Geographical \u002F social reasons preventing attending study centre\n* Unable to complete study assessments.\n* Severe non-cardiac disease expected to reduce life expectancy \\\u003C 5 years\n* Current participation in a blinded drug interventional trial (or treatment within 4 weeks)","ALL","10 Years",{"count":79,"type":80},750,"ESTIMATED","OBSERVATIONAL","Genetic cardiomyopathy is increasingly recognised and can lead to heart failure, arrhythmia and sudden cardiac death. Some gene positive patients have rapidly progressive disease with high rates of heart failure and cardiac transplantation, while others present with SCD. Other gene positive patients will never develop cardiomyopathy. At present, we cannot distinguish between these groups and rely on expensive and labour-intensive surveillance by electrocardiography, echocardiography and sometimes cardiac magnetic resonance imaging.\n\nThis study will investigate existing and novel biomarkers (including blood, urine electrocardiographic and imaging) at various stages of disease in patients with a personal or family history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant, which are known to cause cardiomyopathy.",[84,85,86],"Cardiomyopathies","Genetic Predisposition","Cardiomyopathy, Primary",[88,89,90],"Cardiomyopathy","Genetic","Biomarkers","2024-07-01",{"date":93,"type":94},"2024-07-03","ACTUAL",{"date":96,"type":94},"2024-06-26",{"date":98,"type":80},"2027-03-19",{"name":5,"class":6},1]