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NCT Number: NCT07141628

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

lipoprotein A level dosing

Diagnostic Test

Plasma levels measured in mmol/l

Primary outcomes

  1. Link between hyperlipoproteinemia A and a first event of cardiovascular death

    Time frame: 18 months

    cardiovascular death: yes/no

  2. Link between hyperlipoproteinemia A and a first event of myocardial infarction

    Time frame: 18 months

    myocardial infarction: yes/no

  3. Link between hyperlipoproteinemia A and a first event of stroke

    Time frame: 18 months

    stroke: yes/no

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

    Time frame: 18 months

    peripheral artery disease stage 4: yes/no

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

    Time frame: 18 months

    initiation of renal replacement therapy: yes/no

Secondary outcomes

  1. Rate of hyperlipoproteinemia A

    Time frame: Baseline (Day 0)

    defined as a lipoprotein A level > 125 nmol/L

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

    Time frame: Baseline (Day 0)

    Ischemic heart disease: yes/no

  3. Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion

    Time frame: Baseline (Day 0)

    Ischemic stroke: yes/no

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

    Time frame: Baseline (Day 0)

    Calcified aortic stenosis: yes/no

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

    Time frame: Baseline (Day 0)

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

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

    Time frame: Baseline (Day 0)

    Vascular nephropathy: yes/no

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

    Time frame: Month 18

    coronary artery or limb angioplasty: yes/no

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

    Time frame: Month 18

    hospitalization for cardiac decompensation: yes/no

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

    Time frame: Month 18

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

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier Moranne

CONTACT

[email protected]

04.66.68.32.59

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: LPACKD45

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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