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Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.

RecruitingNAAges 18 Years - anyAllOdense University Hospital
NCT05614219 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Familial hypercholesterolemia is the most common inherited disease of the lipid metabolism, however it remains underdiagnosed. Only 15 % of 30.000 possible patients have been found in Denmark. This quality assessing project will through a step wedge cluster randomized controlled trial evaluate establishment of a biochemistry interpretive comment on elevated LDL-C levels. The study will test if the comment results in an increase in referred patients to the lipid clinics of Southern Denmark as the primary endpoint, and as the secondary endpoint in more patients diagnosed with familial hypercholesterolemia. The project will run in totally 52 weeks and will in steps initiate the comment from the different laboratories in the Region of Southern Denmark.

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📋 Eligibility rules (as published)
Inclusion Criteria: * All referred patients to the lipid clinics of Southern Denmark * LDL-C ≥ 4 mmol/L in persons under the age of 40. * LDL-C ≥ 5 mmol/L in persons ≥ 40 years. Exclusion Criteria: Pregnancy and Secondary dyslipidemia * Dysregulated diabetes. Hba1C \< 48 * Dysregulated hypothyreosis. Elevated TSH. * Kombined hyperlipidiemia TG \> 4 mmol/L * Nefrotic syndrome: proteinuria \> 3 g/L and s-albumin \< 30 g/l * Cholestasis (alcalic fosfatase \> 105 U/L and GGT \> 55 U/L) 14 days prior to LDL-C measuring * Pharmacological induced hyperlipidimia
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What it tests

  • Biochemistry interpretive comment on elevated LDL-C levels
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Where

2 sites
Odense University Hospital
Odense, Denmark
Departement of Cardiology, Odense University Hospital
Odense C, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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