Effect of prolonged cholesterol lowering treatment on trained immunity of monocytes in patients with elevated levels of LDL-cholesterol

Completed

• Conditions: Cardiovascular disease; hypercholesterolemia; 10003216

• Registration Number: NL-OMON49515
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients:
- Aged 18 years or older
- They are eligible for participation if they fulfil the criteria for
*possible* FH (3-5 points), *probable* FH (6-8 points) or *definitive* FH (>8
points), according to the Dutch Lipid Clinic Network diagnostic criteria for
familial hypercholesterolemia and untreated LDL levels >4.9 mmol/l and
requiring lipid lowering treatment according to the treating physician
- No previous cardiovascular events
- Written informed consent

Control subjects:
- Age 18 years or older
- LDL cholesterol <3.5 mmol/l
- No previous cardiovascular events
- Written informed consent

Exclusion Criteria

- Current lipid lowering treatment or treatment with lipid lowering drugs in
the past year.
- Age <18 years
- Inability to personally provide written informed consent (e.g. for linguistic
or mental reasons)
- Current treatment for maliganancy
- Acute or chronic infections with fever at the time of participation
- Medical history of any disease associated with immune deficiency (either
congenital or acquired, including chemotherapy, chronic steroid use, organ
transplant)
- Clinically significant infections within 1 months prior to study entry
(defined as fever >38.5)
- Previous vaccination within 1 months prior to study entry
- Chronic use of anti-inflammatory drugs such as NSAIDs (acetylsalicylic acid
<100 mg/day excluded

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In this study we want to evaluate the long term effect of cholesterol lowering<br /><br>treatment (1year) on the circulating innate immune cell in patietns with<br /><br>familial hypercholesterolemia. This most important question is if long term<br /><br>treatment can effect the trained immunity phenotype. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>nvt</p><br>