NCT05962827 Testing for Increased Lipoproteins (a) [LP(a)] in Lymphedema Patients: Li-LY
| NCT ID | NCT05962827 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-12-08 |
| Primary Completion | 2026-08-11 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-12-08 with a primary completion date of 2026-08-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Verena FASSBENDER
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Frequently Asked Questions
Who can join the NCT05962827 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05962827 currently recruiting?
Yes, NCT05962827 is actively recruiting participants. Contact the research team at fassbender.v@chu-nice.fr for enrollment information.
Where is the NCT05962827 trial being conducted?
This trial is being conducted at Nice, France, Nice, France.
Who is sponsoring the NCT05962827 clinical trial?
NCT05962827 is sponsored by Centre Hospitalier Universitaire de Nice. The principal investigator is Verena FASSBENDER at Centre Hospitalier Universitaire de Nice. The trial plans to enroll 100 participants.