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

N/ANot Yet RecruitingNCT07141628

Centre Hospitalier Universitaire de Nīmes300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

CKD Cardiovascular Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Familial hypercholesterolemia * Morbid obesity (BMI \> 40 kg/m2). * Persons deprived of their liberty by a judicial or administrative decision, persons receiving psychiatric care, and persons admitted to a health or social care facility for purposes other than research (Article L1121-6 of the French Public Health Code)

Outcomes

Primary Outcomes

Link between hyperlipoproteinemia A and a first event of cardiovascular death

cardiovascular death: yes/no

Time frame: 18 months

Link between hyperlipoproteinemia A and a first event of myocardial infarction

myocardial infarction: yes/no

Time frame: 18 months

Link between hyperlipoproteinemia A and a first event of stroke

stroke: yes/no

Time frame: 18 months

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

Link between hyperlipoproteinemia A and a first event of initiation of renal replacement therapy

initiation of renal replacement therapy: yes/no

Time frame: 18 months

Secondary Outcomes

Rate of hyperlipoproteinemia A

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

Time frame: Baseline (Day 0)

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

Ischemic heart disease: yes/no

Time frame: Baseline (Day 0)

Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion

Ischemic stroke: yes/no

Time frame: Baseline (Day 0)

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

Calcified aortic stenosis: yes/no

Time frame: Baseline (Day 0)

Link between hyperlipoproteinemia A and a history of lower limb arterial disease stage 2-4 at inclusion

Lower limb arterial disease stage 2-4: yes/no

Time frame: Baseline (Day 0)

Link between hyperlipoproteinemia A and a history of vascular nephropathy at inclusion

Vascular nephropathy: yes/no

Time frame: Baseline (Day 0)

Link between hyperlipoproteinemia A and a history of arterial angioplasty at any site at inclusion

coronary artery or limb angioplasty: yes/no

Time frame: Month 18

Link between hyperlipoproteinemia A and hospitalization for cardiac decompensation during follow-up

hospitalization for cardiac decompensation: yes/no

Time frame: Month 18

Link between hyperlipoproteinemia A and the occurrence of repeated cardiovascular events during follow-up

Cumulative events from the following: myocardial infarction, stroke, PAD stage 4, initiation of renal replacement therapy, death, arterial angioplasty at any site, cardiac decompensation

Time frame: Month 18

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts