[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100330767":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":47,"centralContacts":52,"locations":60,"responsibleParty":82,"collaborators":84,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":10,"enrollmentInfo":99,"targetDuration":10,"studyType":102,"phases":10,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Leicester","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Haemodialysis patients",null,"The plans for patient recruitment were developed in partnership with our local haemodialysis patient participation and involvement group. Patients will be identified from the supportive care register established for haemodialysis patients in Leicester in 2008.\n\nInclusion:\n\n* Prevalent haemodialysis patient (more than 3 months)\n* Active on the supportive care register with anticipated death in the subsequent 12 months\n* Able to give informed consent\n* Consent to donation of heart for research following death\n* Able to understand written and verbal explanations in English\n\nExclusion:\n\n* Contraindication to MRI scan (e.g. pacemaker, incompatible metallic implants, claustrophobia)\n* Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis)\n* Unable to give informed consent\n* Unable to understand written and verbal explanations in English",[13,14,15,16,17],"Diagnostic Test: Cardiac MRI scan","Diagnostic Test: Echocardiogram","Procedure: Cardiac explantation","Diagnostic Test: 48-Hour continuous cardiac monitoring","Diagnostic Test: Blood samples",[19,26,32,37,43],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Cardiac MRI scan","A non-contrast cardiac MRI (CMR) scan at 3-Tesla platform (Skyra, Siemens Medical Imaging, Erlangen, Germany).\n\nThis non-contrast CMR scan will principally determine: Left ventricular (LV) mass and volumes\u002Fejection fraction and; fibrosis using T1 mapping.",[9],[25],"CMR",{"type":20,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Echocardiogram","Assessments will include: LV size and function as per the American Society of Echocardiography guidelines. In addition specific focus will be paid end-diastolic integrated backscatter measurements.",[9],[31],"ECHO",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"PROCEDURE","Cardiac explantation","A limited post-mortem will be performed to retrieve patients' hearts for preparation and storage at St George's University, London where direct comparison will be made between levels of scarring seen directly under the microscope between that on the MRI scans.",[9],{"type":20,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"48-Hour continuous cardiac monitoring","Attach continuous Holter monitor (Schiller, medilog®AR12 plus\u002FAR4 plus\u002FFD5 plus, Baar, Switzerland) that will start before dialysis and terminate just before the subsequent dialysis treatment 48h later.",[9],[42],"Holter",{"type":20,"name":44,"description":45,"armGroupLabels":46,"otherNames":10},"Blood samples","Collect blood samples from the arterial needle before dialysis. Approximately 30 millilitres of blood will be collected and then be pipetted into cryotubes and frozen at -80°C in an electronically monitored freezer for analysis in batches throughout the study. These samples will be used to investigate the relationship between circulating biomarkers of fibrosis, the MRI scans and the histological samples.",[9],[48],{"name":49,"affiliation":50,"role":51},"James Burton, DM, FRCP","Associate Professor in Renal Medicine","PRINCIPAL_INVESTIGATOR",[53,57],{"name":49,"role":54,"phone":55,"phoneExt":10,"email":56},"CONTACT","+44 (0)116 2588043","jb343@le.ac.uk",{"name":58,"role":54,"phone":55,"phoneExt":10,"email":59},"Matthew Graham-Brown, MBChB, MRCP","mgb23@le.ac.uk",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"University Hospitals of Leicester NHS Trust","RECRUITING","Leicester","Leicestershire","LE5 4PW","United Kingdom","UK",{"type":70,"coordinates":71},"Point",[72,73],-1.13169,52.6386,{"lat":73,"lon":72},[76,79],{"name":77,"role":54,"phone":78,"phoneExt":10,"email":56},"James Burton, FRCP","01162588043",{"name":80,"role":81,"phone":10,"phoneExt":10,"email":10},"Matthew Graham-Brown, MRCP","SUB_INVESTIGATOR",{"type":83,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[85,87],{"name":86,"class":6},"University Hospitals, Leicester",{"name":88,"class":6},"St George's, University of London","100330767","validating-novel-non-contrast-cardiac-mri-imaging-in-haemodialysis-patients-100330767",false,"NCT03586518","Validating Novel, Non-contrast Cardiac MRI Imaging in Haemodialysis Patients","Validating the Accuracy of Novel, Non-contrast, Cardiac Magnetic resOnaNce Imaging in Defining Myocardial FIbRosis in Patients With End-stage Renal Disease on haeModialysis: the CONFIRM Study","CONFIRM","Inclusion Criteria:\n\n* Prevalent haemodialysis patient (more than 3 months)\n* Active on the supportive care register with anticipated death in the subsequent 12 months\n* Able to give informed consent\n* Consent to donation of heart for research following death\n* Able to understand written and verbal explanations in English\n\nExclusion Criteria:\n\n* Contraindication to MRI scan (e.g. pacemaker, incompatible metallic implants, claustrophobia)\n* Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis)\n* Unable to give informed consent\n* Unable to understand written and verbal explanations in English","ALL","18 Years",{"count":100,"type":101},9,"ESTIMATED","OBSERVATIONAL","There are currently no good ways of measuring levels of scarring in the hearts of patients with advanced kidney disease and patients on dialysis, although recent research has shown a new cardiac MRI technique, called native T1 mapping, may provide a solution to this. To assess the accuracy of this novel technique in dialysis patients, it is essential to undertake a study which compares native T1 mapping to actual levels of scarring in the hearts of patients on dialysis.",[105,106],"End Stage Kidney Disease","Fibrosis Myocardial",[108,109,110,111],"Cardiac MRI","Hemodialysis","Myocardial Fibrosis","Myocardial Inflammation","2025-04-15",{"date":114,"type":115},"2025-04-18","ACTUAL",{"date":117,"type":115},"2019-11-03",{"date":119,"type":101},"2025-12-31",{"name":5,"class":6},1]