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

Официальное название

Etude de l'hyperlipoprotéinémie A Comme Marqueur de Risque Cardio-vasculaire Chez Les Patients Atteints de Maladie rénale Chronique au Stade 4

Обзор

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.

Вмешательства

• Диагностический тест lipoprotein A level dosing
  Plasma levels measured in mmol/l

Первичные конечные точки

• Link between hyperlipoproteinemia A and a first event of cardiovascular death [Срок оценки: 18 months]
• Link between hyperlipoproteinemia A and a first event of myocardial infarction [Срок оценки: 18 months]
• Link between hyperlipoproteinemia A and a first event of stroke [Срок оценки: 18 months]
• Link between hyperlipoproteinemia A and a first event of peripheral artery disease stage 4 [Срок оценки: 18 months]
• Link between hyperlipoproteinemia A and a first event of initiation of renal replacement therapy [Срок оценки: 18 months]

Вторичные конечные точки (9)

• Rate of hyperlipoproteinemia A [Срок оценки: Baseline (Day 0)]
• Link between hyperlipoproteinemia A and a history of ischemic heart disease at inclusion [Срок оценки: Baseline (Day 0)]
• Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion [Срок оценки: Baseline (Day 0)]
• Link between hyperlipoproteinemia A and a history of calcified aortic stenosis at includion [Срок оценки: Baseline (Day 0)]
• Link between hyperlipoproteinemia A and a history of lower limb arterial disease stage 2-4 at inclusion [Срок оценки: Baseline (Day 0)]
• Link between hyperlipoproteinemia A and a history of vascular nephropathy at inclusion [Срок оценки: Baseline (Day 0)]
• Link between hyperlipoproteinemia A and a history of arterial angioplasty at any site at inclusion [Срок оценки: Month 18]
• Link between hyperlipoproteinemia A and hospitalization for cardiac decompensation during follow-up [Срок оценки: Month 18]
• Link between hyperlipoproteinemia A and the occurrence of repeated cardiovascular events during follow-up [Срок оценки: Month 18]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU de Nîmes - Hôpital Universitaire Carémeau — Nîmes

Идентификаторы

NCT: NCT07141628 · NIMAO/2024-2/OM01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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