E78
Conditions
Interventions
Group 1: All patients are treated with lipid apheresis as part of their standard medical care. Lipid apheresis treatments are performed with an in Germany commercially available CE-marked lipid aphere
Sponsors
Apherese Forschungsinstitut
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Indication for lipid apheresis because of isolated Lp(a)-HLP over 60 mg/dl and LDL-cholesterol within the normal range as well as a progressive cardiovascular disease which is clinically and by imaging techniques documented. The competent association of statutory health insurance physicians has checked and approved the indication for lipid apheresis, the health insurance has confirmed reimbursement. Patient is routinely treated with lipid apheresis. Patient has signed informed consent.
Exclusion criteria
Exclusion criteria: Patient doesn’t agree to participate. Treating physician doesn’t want to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of prospectively documented cardiovascular events within the first 2 years after commencing lipid apheresis with retrospectively recorded cardiovascular events within the two years before lipid apheresis. 2024 retrospective extension of the study to a period until 5 years prior and 12 years after initiation of lipid apheresis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Documentation of safety and tolerability of lipid apheresis by analyzing the performance of single treatments at the beginning and every 6 months. Documentation of health related quality of life before and during apheresis treatments by using the SF36 questionnaire. | — |
Countries
Germany
Contacts
Public ContactReinhard Klingel
Apherese Forschungsinstitut
Outcome results
None listed