Novel Cardiovascular Biomarkers in Patients With Kidney Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLiverpool University Hospitals NHS Foundation Trust
About this trial
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.
At 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.
Several 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/lipids). 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Patients with pre-existing heart disease will be excluded.
Patients with active cancer.
Trial population
Adults aged ≥45 years (or ≥18 with a history of diabetes) for both cases and controls. Cardiovascular risk steeply increases after the age of 45 years. For this exploratory analysis, we intend to target patients at high risk of cardiovascular disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cardiac Biomarkers
Diagnostic testBlood 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.
Lipidomics
Diagnostic testBlood 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.
Proteomics
Diagnostic testBlood 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Cases (N=50):3 interventions
Group B: Controls (N=50)3 interventions
Trial outcomes
Primary outcomes
1
Major Adverse Cardiac Events
An exploratory analysis of all-cause mortality and Major Adverse Cardiac Events (MACE). MACE is defined as a composite of CV death, Ischemic Heart Disease (IHD), myocardial infarction (MI), stroke/TIA, Heart Failure, Cardiac revascularisation (percutaneous coronary intervention and coronary artery bypass graft), carotid endarterectomy. The follow-up will be 12 months for all patients. This will be correlated with biomarker, proteomic and lipidomic data.
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: