familial hypercholesterolemia genetic elevated 'bad' cholesterol
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients: - Age > 18 years old - Familial hypercholesterolemia (according to Dutch Lipid network criteria) - No previous cardiovascular events - No current lipid lowering treatment - LDL-cholesterol > 4.9 mmol/L;Healthy controls: - Age >= 18 years old - No (previous) clinically significant health problems - No current medication use
Exclusion criteria
Exclusion criteria: 1. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator. 2. Chronic or recent (10 3. Auto-immune diseases 4. Recent or chronic immunosuppressant or antibiotic usage 5. Type I or II diabetes mellitus 6. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main primary outcome is difference in CFU-GM assay (= function) and flow cytometry (=phenotype) of HSCs of FH patients before versus after treatment with a statin/PCSK9-inhibitor compared to healthy HSCs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are difference in lipid accumulation in FH HSCs and monocytes before and after treatment, flow cytometry (=phenotype) of FH HSCs compared to flow cytometry of circulating monocytes of FH patients and epigenetic and metabolic changes in FH HSCs and monocytes before and after treatment with a statin/PCSK9-inhibitor. This will be compared to healthy HSCs and monocytes | — |
Countries
The Netherlands