E78.5
Conditions
Interventions
Group 1: Patients with marked hypercholesterolemia or Lp(a) hypercholesterolemia on chronic lipoprotein apheresis or statin or PCSK9 inhibitor therapy.
Exosomes will be determined from whole blood und
Sponsors
Nephrologisches Zentrum Göttingen
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Familial hypercholesterolemia (HLP IIa) and a history of a cardiovascular event (CHD, PAVK, apoplexy, significant plaques). - therapy with a statin for 6 months in monotherapy or in combination with PCSK-9 inhibition and or apheresis therapy. - presence of a written informed consent
Exclusion criteria
Exclusion criteria: Known intolerance or relevant adverse events to statins in the past history - new-onset intolerance to any of the therapies used - lack of capacity to give consent - withdrawal of consent - insufficient mental capacity (psychiatric treatment) - pregnancy - preterminal malignant disease - malignant hypertension - acute renal failure - untreated diabetes mellitus - untreated hyper- or hypothyroidism - clinically important hepatic, gastrointestinal, hematologic, pulmonary, or neurologic disorders - alcohol, drug or medication abuse - occurrence of serious complications (Serious Adverse Events) - low hemoglobin level (<10 g/dl)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of Exosomes Exosomes from plasma are isolated using the ultrafiltration method by Merck and analyzed using a Nanosight LM14C. | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact of lipid-lowering therapy on exosomes on exosome concentration also in relation to other lipid particles such as LDL-C or Lp(a). | — |
Countries
Germany
Contacts
Public ContactVolker Schettler
Nephrologisches Zentrum Göttingen
Outcome results
None listed