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Recruiting Not applicable

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

NCT05962827 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-12-08
Last updated
2026-08-31

Condition(s) studied

Lymphedema

Investigational drug(s) / intervention(s)

lipoprotein (a)

lipoprotein (a): dosage of lipoprotein (a)

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Patients over 18 years of age. * Patient with primary or secondary lymphedema confirmed at consultation or in day hospital. * Signature of informed consent. * Person affiliated to or benefiting from a social security scheme Exclusion Criteria: * Person refusing informed consent. * Pregnant or breast-feeding women (urine pregnancy test performed in women of -childbearing age). * Patients undergoing secondary cardiovascular prevention (MI, stroke, AOMI, etc.). * Persons deprived of their liberty by judicial or administrative decision, persons under legal protection.

Primary outcome measure(s)

  • Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with primary or secondary lymphedema — day 0
    The primary endpoint will be lipoprotein (a) \> 30 mg/dL, defining hyperlipoproteinemia (a).

Trial sites (2)

FacilityCityRegionStatus
Chu de Nice Nice France Recruiting
Centre antoine lacassagne Nice France Terminated
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05962827 on ClinicalTrials.gov ↗ ← All trials in France