Hyperlipoproteinemia A as a Marker of Cardiovascular Risk in Patients With Stage 4 Chronic Kidney Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

lipoprotein A level dosing: Plasma levels measured in mmol/l

Study summary

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

Primary outcome measure(s)

• Link between hyperlipoproteinemia A and a first event of cardiovascular death — 18 months
  cardiovascular death: yes/no
• Link between hyperlipoproteinemia A and a first event of myocardial infarction — 18 months
  myocardial infarction: yes/no
• Link between hyperlipoproteinemia A and a first event of stroke — 18 months
  stroke: yes/no
• Link between hyperlipoproteinemia A and a first event of peripheral artery disease stage 4 — 18 months
  peripheral artery disease stage 4: yes/no
• Link between hyperlipoproteinemia A and a first event of initiation of renal replacement therapy — 18 months
  initiation of renal replacement therapy: yes/no

Trial sites (1)

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