Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT05962827

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

Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-12-04

100

Participants Needed

2

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age
  • Confirmed primary or secondary lymphedema at consultation or in day hospital
  • Signed informed consent
  • Affiliated to or benefiting from a social security scheme
Not Eligible

You will not qualify if you...

  • Refusal to provide informed consent
  • Pregnant or breastfeeding women (urine pregnancy test done for women of childbearing age)
  • Patients undergoing secondary cardiovascular prevention (history of myocardial infarction, stroke, or arterial occlusive disease)
  • Persons deprived of liberty by judicial or administrative decision or under legal protection

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Chu de Nice

Nice, France, France, 06000

Actively Recruiting

2

Centre antoine lacassagne

Nice, France, France, 06003

Terminated

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Research Team

V

Verena FASSBENDER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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