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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphedema
• Intervention / Treatment: Diagnostic test: lipoprotein (a)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Verena FASSBENDER; Phone Number: 0492034702; Email: fassbender.v@chu-nice.fr

Study Locations

• France
  • France
    • Nice, France, France, 06000
      • Recruiting
      • CHU de Nice
      • Contact: Verena FASSBENDER; Email: fassbender.v@chu-nice.fr
      • Principal Investigator: Verena FASSBENDER
    • Nice, France, France, 06003
      • Terminated
      • Centre Antoine Lacassagne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with lymphedema; The primary endpoint will be lipoprotein (a) > 30 mg/dL, defining hyperlipoproteinemia (a).	Diagnostic test: lipoprotein (a); dosage of lipoprotein (a)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the prevalence of hyperlipoproteinemia (a) in a population of patients with primary or secondary lymphedema	The primary endpoint will be lipoprotein (a) > 30 mg/dL, defining hyperlipoproteinemia (a).	day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the modification of the SCORE-2 /SCORE-OP index of cardiovascular risk assessment at re-evaluation,	To study the modification of the SCORE-2 /SCORE-OP index	day 5
To study the modification of the cardiovascular risk assessment calcium score at reassessment, taking into account the presence of hyperlipoproteinemia (a).	cardiovascular risk assessment calcium score at reassessment,	day 5

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Verena FASSBENDER, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): August 11, 2026

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 22-AOI-05; 2023-A00407-38 (Other Identifier: CHU de Nice)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No