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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05962827
Acronym
LiLY
Enrollment
100
Registered
2023-07-27
Start date
2023-12-08
Completion date
2027-06-08
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTlipoprotein (a)

dosage of lipoprotein (a)

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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.

Design outcomes

Primary

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

Secondary

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

Countries

France

Contacts

CONTACTVerena FASSBENDER
fassbender.v@chu-nice.fr0492034702
PRINCIPAL_INVESTIGATORVerena FASSBENDER

Centre Hospitalier Universitaire de Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026