[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518993":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":10,"responsibleParty":42,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":10,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":10},{"fullName":5,"class":6},"Liverpool University Hospitals NHS Foundation Trust","OTHER_GOV",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Cases (N=50):",null,"Patients with incident ESKD managed by HD (n=50)",[13,14,15],"Diagnostic Test: Cardiac Biomarkers","Diagnostic Test: Lipidomics","Diagnostic Test: Proteomics",{"label":17,"type":10,"description":18,"interventionNames":19},"Controls (N=50)","Patients with Incident ESKD managed by PD (n=20) Patients with CKD stage 3-4 (not on dialysis) with hypertension as a key risk factor for CKD and CVD (n=30)",[13,14,15],[21,26,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DIAGNOSTIC_TEST","Cardiac Biomarkers","Blood samples will be collected at baseline (within 6 weeks of dialysis start), at 6 months post-commencement and 12 months post-commencement of haemodialysis. The blood sampling will be mid-week samples taken at the dialysis start for haemodialysis patients, with a similar approach for the PD controls. For the CKD controls, the blood samples will be scheduled around routine clinic attendance, adhering where possible to the time intervals for HD cases and PD controls.",[9,17],{"type":22,"name":27,"description":24,"armGroupLabels":28,"otherNames":10},"Lipidomics",[9,17],{"type":22,"name":30,"description":24,"armGroupLabels":31,"otherNames":10},"Proteomics",[9,17],[33],{"name":34,"affiliation":35,"role":36},"Anirudh Rao, PhD","Liverpool University Hospital NHS Trust","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":10,"email":41},"CONTACT","01517063487","anirudh.rao@liverpoolft.nhs.uk",{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100518993","novel-cardiovascular-biomarkers-in-patients-with-kidney-disease-100518993",false,"NCT06037759","Novel Cardiovascular Biomarkers in Patients With Kidney Disease","CBKD","Inclusion Criteria:\n\nPatients aged≥45 years (or ≥18 with a history of diabetes). b. Cases: Incident haemodialysis patients c. A comparative arm of peritoneal dialysis patients and CKD 3-4 (not on dialysis) with hypertension as a key risk factor for CVD.\n\nd. Capable of understanding the purpose and risks of the study, fully informed, and given informed consent.\n\nExclusion Criteria:\n\n1. Patients with pre-existing heart disease will be excluded.\n2. Patients with active cancer.",true,"ALL","18 Years",{"count":55,"type":56},100,"ESTIMATED","OBSERVATIONAL","Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work as well as they should. End-stage kidney failure (ESKD) is the final, irreparable stage of chronic kidney disease (CKD), where kidney function has worsened, so the kidneys can no longer function independently.\n\nAt this stage, dialysis is required to remove waste products and excess fluid from the blood. There are two types of dialysis. In haemodialysis (HD), blood is pumped out of the body to an artificial kidney machine and returned to the body by tubes that connect a person to the machine. In peritoneal dialysis (PD), the inside lining of the belly acts as a natural filter. PD has the advantage of being gentler on the heart. HD causes significant stress to the heart by reducing the blood flow to the heart muscle, resulting in heart failure, irregular rhythms, and eventually sudden heart death. A large observational study showed that HD patients had 48% worse survival in the first two years than PD patients.\n\nSeveral molecules ('biomarkers') can be detected in blood and inform doctors of heart damage. Studying the form and function of proteins (Proteomics), including how they work and interact with each other inside cells in patients, could help identify the onset of heart problems. HD patients are also prone to body fat changes (cholesterol\u002Flipids). Due to high cholesterol, there is build-up on the walls of arteries, causing their hardening. In HD patients, this process is faster due to abnormalities in lipid structure. Therefore, studying the heart biomarkers, protein, and lipid makeup of HD patients may help to find people at substantial risk of heart and vascular problems and if they are likely to become unwell due to these heart problems.",[60,61],"Haemodialysis Complication","Major Adverse Cardiac Events",[63,64,65,66,61],"Chronic Kidney Disease","End Stage Kidney Disease","Haemodialysis","Biomarkers","NOT_YET_RECRUITING","2023-09-14",{"date":70,"type":71},"2023-09-18","ACTUAL",{"date":73,"type":56},"2023-11-01",{"date":75,"type":56},"2026-11-01",{"name":5,"class":6}]