About this trial
The blood level of lipoprotein A (Lp(a)) is linked to mutations in gene 6 and is associated with atherothrombotic risk and clinical manifestations such as myocardial infarction, ischemic stroke, and aortic valve calcification and stenosis. Several studies show an increased cardiovascular risk for a level \>125 nmol/L. Patients with severe chronic kidney disease (CKD) or on hemodialysis are at high cardiovascular risk, and Lp(a) levels would allow for better reclassification of this cardiovascular risk in the general population.
The study authors wished to the heterogeneity of the Lp(a) level in the population with CKD stages 4 without renal replacement therapy and to identify whether a high Lp(a) level is associated with cardiovascular comorbidity defined by the presence of cardiovascular comorbidity after adjustment for known risk factors such as diabetic status, obesity, smoking, LDLc level and medical treatment for cardiovascular prevention (statins, etc.). Furthermore, they will evaluate whether there is a link between a high level (\> 125 mmol/l) of Lp(a) at inclusion in the cohort and the occurrence of cardiovascular or renal events (i.e. death of cardiovascular origin or occurrence of MI, stroke, stage 4 peripheral artery disease (PAD) or initiation of renal replacement) over a follow-up period of 18 months which could raise questions about the benefit of a specific treatment which remains to be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
Patient being followed at the Nîmes University Hospital for stage 4 chronic kidney disease without replacement therapy
Patient available for follow-up at 18 months
Disqualifiers
The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
The subject refuses to sign the consent
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
Trial population
Patients with stage 4 chronic kidney disease without replacement therapy followed as outpatients at Nîmes University Hospital.
Trial design
Cohort
Prospective
Treatments tested in this trial
lipoprotein A level dosing
Diagnostic testPlasma levels measured in mmol/l
Treatment groups
Trial outcomes
Primary outcomes
Link between hyperlipoproteinemia A and a first event of cardiovascular death
cardiovascular death: yes/no
Link between hyperlipoproteinemia A and a first event of myocardial infarction
myocardial infarction: yes/no
Link between hyperlipoproteinemia A and a first event of stroke
stroke: yes/no
Link between hyperlipoproteinemia A and a first event of peripheral artery disease stage 4
peripheral artery disease stage 4: yes/no
Secondary outcomes
Rate of hyperlipoproteinemia A
defined as a lipoprotein A level \> 125 nmol/L
Link between hyperlipoproteinemia A and a history of ischemic heart disease at inclusion
Ischemic heart disease: yes/no
Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion
Ischemic stroke: yes/no
Link between hyperlipoproteinemia A and a history of calcified aortic stenosis at includion
Calcified aortic stenosis: yes/no
Sponsors and contacts
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