Status:
UNKNOWN
Long-term Characterization of Lipoprotein Apheresis Technologies for Individual Device Adaption (LOLIDA)
Lead Sponsor:
Technische Universität Dresden
Conditions:
Lipoproteinemia
Apheresis Related Complication
Eligibility:
All Genders
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 aphere...
Detailed Description
Aims The aim of the proposed project is the investigation of Lp(a) kinetics in patients under regular lipoprotein apheresis with regard to short- and long-term changes in diverse clinical parameter co...
Eligibility Criteria
Inclusion
- Inclusion criteria for lipoprotein apheresis in accordance with regulations of the German Federal Joint Committee of physicians and medical insurance companies (G-BA; Gemeinsamer Bundesausschuss der Ärzte und Krankenkassen) are either:
- 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
- Mandatory for inclusion of patients for lipoprotein apheresis is a comprehensive cardiological, angiological and lipidological pre-examination.
- (Deutsches Ärzteblatt 100 (2003), 1595; Deutsches Ärzteblatt 105 (2008), 1778)
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05181969
Start Date
October 1 2014
End Date
December 31 2024
Last Update
January 10 2022
Active Locations (1)
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1
Carl Gustav Carus University Hospital Dresden, Technische Universität Dresden,
Dresden, Germany, 01307