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Testing for Increased Lipoproteins (a) [LP(a)] in Lymphedema Patients: Li-LY

NCT05962827 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-04

No results posted yet for this study

Summary

Lymphedema is a chronic disease that causes lymph to accumulate in the interstitial tissue. The lymphatic network is involved in the metabolism of lipids and lipoproteins, and this accumulation leads to lipid deposits in the tissues involved. The level of lipoprotein(a) \[LP(a)\] has been shown to be a cardiovascular risk factor, which is partly genetically determined and influenced by certain factors (chronic renal failure, statin treatment, sporting activity or a diet low in saturated fatty acids...). Plasma levels of LP(a) lipoproteins (a) are linearly associated with an increased risk of myocardial infarction and carotid and femoral vascular stenosis. We currently manage patients with primary or secondary lymphedema, whatever the etiology, in the vascular medicine and explorations unit at Nice University Hospital.

Those taking part in intensive inpatient decongestive therapy benefit from a blood test, in particular for lipids \[total cholesterol, triglycerides, HDL and LDL cholesterol, apolipoproteins A and B and Lp(a)\]. Our team observed an elevated Lp(a) level \>30 mg/dL in 10 of the 17 patients in whom we carried out this test (whether or not dyslipidemia existed, and whether or not it was known or treated). This is a very high prevalence compared with the general population, in whom an increased level is found in 25% of patients.

In view of the impact of Lp(a) on cardiovascular risk and the involvement of the lymphatic system in lipoprotein metabolism, it seems essential to verify our preliminary results on a larger population. In this multicenter cross-sectional trial, we propose to perform Lp(a) lipoprotein assays in lymphedema patients to determine whether there is an increase in this marker in this pathological context. We will also study the concordance of this level with cardiovascular risk assessment scores such as SCORE2/SCORE2-OP and the coronary calcium score. We will look for factors influencing plasma LP(a) levels, both general factors suspected of playing a role and factors specific to lymphedema.

Conditions

  • Lymphedema

Interventions

DIAGNOSTIC_TEST

lipoprotein (a)

dosage of lipoprotein (a)

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Verena FASSBENDER · Centre Hospitalier Universitaire de Nice

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-08
Primary Completion
2026-08-11
Completion
2026-08-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05962827 on ClinicalTrials.gov