Exosome analysis in patients with marked hypercholesterolemia or Lp(a) hypercholesterolemia receiving chronic lipoprotein apheresis or PCSK9 inhibitor therapy.
- Conditions
- E78.5Hyperlipidaemia, unspecified
- Registration Number
- DRKS00031699
- Lead Sponsor
- ephrologisches Zentrum Göttingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
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
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)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method