Trained immunity in children with FH that undergo cholesterol lowering treatment

Trained immunity in children with FH that undergo cholesterol lowering treatment - Trained immunity in children with FH

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56081

Enrollment

Registered

2023-10-24

Start date

2023-10-22

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Familial hypercholesterolemia hereditary high cholesterol

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 8-18 yrs old FH (by genetics or EASCP criteria) and LDLC levels above 3.5 mmol/L and requiring lipid lowering treatment according to the treating physician No previous cardiovascular events. Written informed consent from the parents/legal representatives or patients depending on their age prior to participation in the study

Exclusion criteria

Exclusion criteria: - Current lipid lowering treatment or treatment with lipid lowering drugs in the past year - Parents inability to provide written informed consent (for linguistic, intellectual or mental reasons) - Current treatment for malignancy - 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 above 38.5) - Previous vaccination within 1 months prior to study entry - Chronic use of anti-inflammatory drugs such as NSAIDs (acetylsalicylic acid below 100 mg/day excluded)

Design outcomes

Primary

Measure	Time frame
In the children with FH, blood will be drawn before start of statins and 3 and 12 months after initiation of statin treatment. In the normocholesterolemic controls (only in Oslo), blood will only be drawn once. Plasma will be stored and peripheral blood mononuclear cells will be isolated and viably frozen at each study site. After inclusion is complete, all samples will be shipped to Oslo, Norway for analysis of cytokine production capacity upon ex vivo stimulation with various atherogenic stimuli and flow cytometric analysis. Monocytes will be isolated for RNA sequencing and epigenetic analyses. The primary endpoint is LPS-induced IL-1b release in patients with FH compared to controls. Secondary endpoint is the effect of 3- and 12-month statin treatment compared to the baseline situation in children with FH.	—

Measure

Time frame

In the children with FH, blood will be drawn before start of statins and 3 and 12 months after initiation of statin treatment. In the normocholesterolemic controls (only in Oslo), blood will only be drawn once. Plasma will be stored and peripheral blood mononuclear cells will be isolated and viably frozen at each study site. After inclusion is complete, all samples will be shipped to Oslo, Norway for analysis of cytokine production capacity upon ex vivo stimulation with various atherogenic stimuli and flow cytometric analysis. Monocytes will be isolated for RNA sequencing and epigenetic analyses. The primary endpoint is LPS-induced IL-1b release in patients with FH compared to controls. Secondary endpoint is the effect of 3- and 12-month statin treatment compared to the baseline situation in children with FH.

—

Secondary

Measure	Time frame
Secondary endpoint is the effect of 3- and 12-month statin treatment compared to the baseline situation in children with FH.	—

Countries

Netherlands

Outcome results