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Long-term Characterization of Lipoprotein Apheresis Technologies for Individual Device Adaption (LOLIDA)

NCT05181969 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-01-10

No results posted yet for this study

Summary

Lipoprotein apheresis is often applied as the final treatment of patient with severe and medication resistant dyslipidemia and progressive atherosclerosis. The high effectiveness of lipoprotein apheresis to improve the patient's metabolic situation and thereby strongly minimize the incidence of cardiovascular events was confirmed by a variety of studies.

While in the past years, mostly patients with severe homo- or heterozygous familial hypercholesterolemia (FH) or otherwise highly elevated LDL-cholesterol were subjected to lipoprotein apheresis, currently the major indication for lipoprotein apheresis is a critical elevated plasma level of lipoprotein (a) \[Lp(a)\] in patients with severe cardiovascular events. Even if it is now widely accepted that Lp(a) is an independent risk factor for cardiovascular diseases due to its pro-atherogenic potential, the exact molecular mechanisms by which Lp(a) contributes to the atherosclerotic process remain unclear. Despite rigorous reduction of plasma Lp(a)-levels during lipoprotein apheresis newly occurring cardiovascular events cannot prevented in all patients. Specific pleiotropic effects of apheresis technologies are supposed to be critically involved in the clinical outcome. By measurement of a wide variety of cardio-metabolic biomarkers playing a role in inflammation, endothelial dysfunction, lipid metabolism or blood pressure regulation during repeated Lp(a) lowering by various apheresis methods may allow the identification of clusters of risk factors determining clinical outcome and give the biological basement for an optimized individual lipoprotein apheresis therapy.

Conditions

Interventions

DEVICE

Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV)

Lipoprotein apheresis Method I

DEVICE

Lipid filtration (Octo Nova®, Diamed Medizintechnik)

Lipoprotein apheresis Method II

DEVICE

Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius)

Lipoprotein apheresis Method III

DEVICE

Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec)

Lipoprotein apheresis Method IV

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181969 on ClinicalTrials.gov