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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Nīmes

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • lipoprotein A level dosing

    Diagnostic test

    Plasma levels measured in mmol/l

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Patients with stage 4 chronic kidney disease without replacement therapy1 intervention

Trial outcomes

Primary outcomes

1

Link between hyperlipoproteinemia A and a first event of cardiovascular death

cardiovascular death: yes/no

Time frame
18 months
2

Link between hyperlipoproteinemia A and a first event of myocardial infarction

myocardial infarction: yes/no

Time frame
18 months
3

Link between hyperlipoproteinemia A and a first event of stroke

stroke: yes/no

Time frame
18 months
4

Link between hyperlipoproteinemia A and a first event of peripheral artery disease stage 4

peripheral artery disease stage 4: yes/no

Time frame
18 months

Secondary outcomes

1

Rate of hyperlipoproteinemia A

defined as a lipoprotein A level \> 125 nmol/L

Time frame
Baseline (Day 0)
2

Link between hyperlipoproteinemia A and a history of ischemic heart disease at inclusion

Ischemic heart disease: yes/no

Time frame
Baseline (Day 0)
3

Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion

Ischemic stroke: yes/no

Time frame
Baseline (Day 0)
4

Link between hyperlipoproteinemia A and a history of calcified aortic stenosis at includion

Calcified aortic stenosis: yes/no

Time frame
Baseline (Day 0)

Other outcomes

Sponsors and contacts

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