Biomarkers of Cardiovascular Complications in Chronic Kidney Disease

Study Overview
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Brief Summary
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Identification of new retention solutes associated with cardiovascular (CV) toxicity in Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological mechanisms at stake and to prevent CKD-associated mortality and morbidity. For a molecule to be defined as a toxic retention solute, plasma accumulation in the course of CKD has to be demonstrated but also proof needs to be made that plasma accumulation during CKD is indeed associated with an increased risk of CV complications. Moreover, precise determination of the plasma concentration has to be performed in order to later study in vitro and in vivo the toxic mechanisms involved. Based on previous results of plasma proteome analysis using mass spectrometry, a previous study has selected 10 promising protein candidates. These proteins accumulated in the plasma of patients during CKD progression and are known to be associated with CV events in non-CKD patients. The objective of the present study is now to 1) evaluate the association of the plasma accumulation of the 10 retention solutes with CV complications in CKD patients and 2) determine their plasma concentration using ELISA. One hundred and seventy six patients with advanced CKD will be included and divided in 2 groups: 44 patients with history of CV complications in the past 4 years and 132 patients free of any CV complications.

Official Title
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Identification of BIOmarkers for Detection and Understanding of Cardiovascular Complications in Chronic Kidney Disease

Conditions
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Chronic Renal Disease

Intervention / Treatment
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* Diagnostic Test: Biological determination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with stage 4 or 5 CKD. Exclusion Criteria: patient with stage 1, 2 or 3 CKD patient with solid tumor patient with malignant blood disease patient with acute kidney disease in the past 3 months patient with acute glomerulonephritis in the past 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiovascular complication<br>patients with history of CV complications in the past 4 years had biological determination | Diagnostic Test: Biological determination<br>* Evaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients<br>|
| No cardiovascular complication<br>patients free of any CV complications had biological determination | Diagnostic Test: Biological determination<br>* Evaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma accumulation of new retention solutes | evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine their plasma concentration | determine their plasma concentration using ELISA | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular complications, biomarkers