[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575756":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":72,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":10,"enrollmentInfo":90,"targetDuration":10,"studyType":93,"phases":10,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Fabry Disease",null,"Patients with a genetically verified diagnosis of Fabry disease, grouped by the presence of left ventricular hypertrophy",[13,14],"Diagnostic Test: Cardiac Magnetic Ressonance Imaging","Diagnostic Test: 82Rubidium-positron emission tomography and computer-tomography",{"label":16,"type":10,"description":17,"interventionNames":18},"Controls","Healthy age- and sex-matched controls",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Cardiac Magnetic Ressonance Imaging","CMR-protocol with gadolinium contrast",[16,9],[26],"CMR",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"82Rubidium-positron emission tomography and computer-tomography","cardiac Rb-PET protocol",[16,9],[32],"82Rb-PET\u002FCT",[34],{"name":35,"affiliation":5,"role":36},"Caroline Kistorp, Professor","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","35459642","0045","caroline.michaela.kistorp@regionh.dk",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Niels Høeg Brandt-Jacobsen, PhD, MD","35458177","niels.hoeeg.brandt-jacobsen.01@regionh.dk",[48],{"facility":49,"status":50,"city":51,"state":10,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":56,"coordinates":57},"Point",[58,59],12.56553,55.67594,{"lat":59,"lon":58},[62,65,68,71],{"name":63,"role":39,"phone":64,"phoneExt":10,"email":42},"Caroline Kistorp, Professor, PhD, MD","004535459642",{"name":66,"role":39,"phone":67,"phoneExt":10,"email":46},"Niels H Brandt-Jacobsen, MD, PhD","004535458177",{"name":69,"role":70,"phone":10,"phoneExt":10,"email":10},"Niels H Brandt-Jacobsen, PhD, MD","SUB_INVESTIGATOR",{"name":63,"role":36,"phone":10,"phoneExt":10,"email":10},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Caroline Michaela Kistorp","Professor",[77],{"name":78,"class":79},"Sanofi","INDUSTRY","100575756","the-role-of-cardiac-inflammation-endothelial-dysfunction-and-fibrosis-in-fabry-disease-100575756",false,"NCT06776419","the Role of cArdiac Inflammation, endoThelial Dysfunction, and FIbrosis in fabrY Disease","RATIFY","Patients with Fabry disease (1)\n\nInclusion Criteria:\n\n* Male and female individuals with a genetically-verified diagnosis of Fabry disease\n* ≥ 18 years of age\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Any contraindication against a pharmacologically induced rest-stress PET\u002FCT protocol according to local safety procedures such as acute coronary syndrome, severe bronchospasm, severe chronic obstructive pulmonary disease, cardiac arrhythmia.\n* Any contraindication for MRI according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup\u002Ftattoos that cannot be declared MR compatible.\n* Pregnancy\n\nAge and sex-matched healthy controls (2)\n\nInclusion Criteria:\n\n* ≥ 18 years of age\n* Able to give informed consent\n\nExclusion Criteria:\n\n* A genetically-verified diagnosis of Fabry disease.\n* Family member to a patient with a genetically-verified diagnosis of Fabry disease\n* Cancer expected to influence life expectancy.\n* Known heart failure, previous apoplexy or previously established kidney disease.\n* Initiation or change of antihypertensive therapy within 3 months of enrollment.\n* Known LVH as evaluated on echocardiography\n* Any contraindication for a pharmacologically induced stress PET\u002FCT protocol according to local safety procedures such as acute coronary syndrome, severe bronchospasm, severe chronic obstructive pulmonary disease, cardiac arrhythmia.\n* Any contraindication for MRI according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup\u002Ftattoos that cannot be declared MR compatible.\n* Pregnancy",true,"ALL","18 Years",{"count":91,"type":92},54,"ESTIMATED","OBSERVATIONAL","The overall objective of this study is to investigate Fabry-related cardiomyopathy and the use of native T1-mapping, coronary microvascular function, cardiac inflammation, and cardiac injury in an effort to improve the ability to detect disease. The study aims to achieve this by:\n\n1. Investigating the association between cardiac inflammation, fibrosis, and injury against the distribution and degree of microvascular disease in patients with Fabry disease with and without left ventricular hypertrophy (LVH) using cardiac magnetic resonance (CMR) imaging and 82Rubidium Positron emission tomography and computer tomography (82Rb-PET\u002FCT).\n2. Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-related cardiomyopathy.",[96,97],"Fabry Disease","Cardiovascular Diseases",[99,100,101,102,103],"Hypertrophy","Inflammation; Myocardium","Fibrosis Myocardial","Endothelial dysfunction","Coronary Microcirculation","2025-04-04",{"date":106,"type":107},"2025-04-08","ACTUAL",{"date":109,"type":92},"2025-05-01",{"date":111,"type":92},"2031-06-01",{"name":74,"class":6},1]