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

NCT07141628 | Not Yet Recruiting

• 1 other identifier: NIMAO/2024-2/OM01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CKD; Cardiovascular Diseases

Keywords

lipoproteinA

Outcome Measures

Primary Outcomes (5)

• Link between hyperlipoproteinemia A and a first event of cardiovascular death

  cardiovascular death: yes/no

  18 months

• Link between hyperlipoproteinemia A and a first event of myocardial infarction

  myocardial infarction: yes/no

  18 months

• Link between hyperlipoproteinemia A and a first event of stroke

  stroke: yes/no

  18 months

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

  peripheral artery disease stage 4: yes/no

  18 months

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

  initiation of renal replacement therapy: yes/no

  18 months

Secondary Outcomes (9)

• Rate of hyperlipoproteinemia A

  Baseline (Day 0)

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

  Baseline (Day 0)

• Link between hyperlipoproteinemia A and a history ischemic stroke at inclusion

  Baseline (Day 0)

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

  Baseline (Day 0)

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

  Baseline (Day 0)

Study Arms (1)

Patients with stage 4 chronic kidney disease without replacement therapy

Diagnostic Test: lipoprotein A level dosing

Interventions

lipoprotein A level dosing DIAGNOSTIC_TEST

Plasma levels measured in mmol/l

Patients with stage 4 chronic kidney disease without replacement therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage 4 chronic kidney disease without replacement therapy followed as outpatients at Nîmes University Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Olivier Moranne

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Moranne

CONTACT

04.66.68.32.59; olivier.moranne@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-08

Locations

FR (1)