Long-term Characterization of Lipoprotein Apheresis Technologies for Individual Device Adaption (LOLIDA)
LOLIDA
1 other identifier
observational
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 20, 2021
CompletedFirst Posted
Study publicly available on registry
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 10, 2022
December 1, 2021
10.3 years
December 20, 2021
December 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of new biomarkers for individualized assignment of lipoprotein apheresis technology
Characterization of short- and long-term effects of repeated lipoprotein apheresis by dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV), lipid filtration (Octo Nova®, Diamed Medizintechnik), direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius), and TheraSorb™ (Miltenyi Biotec GmbH, Germany) on cardio-metabolic risk factors, including biomarkers of heart failure, inflammation, oxidative stress, endothelial dysfunction and fibrosis.
10 years
Secondary Outcomes (1)
Recordings of newly manifested cardiovascular events
10 years
Study Arms (4)
Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV)
Apheresis therapy
Lipid filtration (Octo Nova®, Diamed Medizintechnik)
Apheresis therapy
Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius)
Apheresis therapy
Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec)
Apheresis therapy
Interventions
Lipoprotein apheresis Method I
Lipoprotein apheresis Method II
Lipoprotein apheresis Method III
Lipoprotein apheresis Method IV
Eligibility Criteria
Patients undegoing lipoprotein apheresis based on the above described inclusion and exclusion criteria
You may qualify if:
- homozygous familial hypercholesterolemia or
- severe hypercholesterolemia in patients after 12 month of dietary intervention and maximal lipid-lowering drug therapy with regard on the overall risk profile of the patient or
- Lp(a) levels \> 120 nmol/L in patients with progressive cardiovascular disease after unsuccessful intervention with established methods of treatment
- (Deutsches Ärzteblatt 100 (2003), 1595; Deutsches Ärzteblatt 105 (2008), 1778)
You may not qualify if:
- Patients after transplantation
- Immunosuppressive therapy (including intake of glucocorticoids within four weeks prior to sample collection)
- uncontrolled arterial hypertension (\>180/110 mm Hg)
- epilepsy
- acute malignant and infectious diseases
- liver disease (gamma-GT \> 1.8 μmol/L×s, ALAT \> 1.5 μmol/L×s),
- severe renal dysfunction (GFR \< 30 ml/min per 1.73 m2)
- smoking
- hypersensitivity against heparin
- participation in another study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carl Gustav Carus University Hospital Dresden, Technische Universität Dresden,
Dresden, 01307, Germany
Biospecimen
Plasma and Serum samples
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2021
First Posted
January 10, 2022
Study Start
October 1, 2014
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 10, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share