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To study the effect of LDL-cholesterol and LDL-cholesterol lowering on hematopoietic stem cells and circulating immune cells in familial hypercholesterolemia patients.

To study the effect of LDL-cholesterol and LDL-cholesterol lowering on hematopoietic stem cells and circulating immune cells in familial hypercholesterolemia patients. - PRIME

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47323
Enrollment
50
Registered
2019-01-21
Start date
2017-07-05
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

familial hypercholesterolemia genetic elevated 'bad' cholesterol

Interventions

Familial hypercholesterolemia
Inflammation

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)