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NCT Number: NCT05962827

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre antoine lacassagne, Nice, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

lipoprotein (a)

Diagnostic Test

dosage of lipoprotein (a)

Primary outcomes

  1. Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with primary or secondary lymphedema

    Time frame: day 0

    The primary endpoint will be lipoprotein (a) > 30 mg/dL, defining hyperlipoproteinemia (a).

Secondary outcomes

  1. To study the modification of the SCORE-2 /SCORE-OP index of cardiovascular risk assessment at re-evaluation,

    Time frame: day 5

    To study the modification of the SCORE-2 /SCORE-OP index

  2. To study the modification of the cardiovascular risk assessment calcium score at reassessment, taking into account the presence of hyperlipoproteinemia (a).

    Time frame: day 5

    cardiovascular risk assessment calcium score at reassessment,

Study contacts

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

Verena FASSBENDER

CONTACT

[email protected]

0492034702

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: LiLY

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2023
Registry last updated
Dec 4, 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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