Tests a lab comment on high cholesterol to find familial hypercholesterolemia
Tests a lab report comment on high LDL cholesterol in adults with familial hypercholesterolemia.
Plain-language title generated from the registry record
Registry title: Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.
Key facts
- Where
- Odense and Odense C, DenmarkSee the 2 sites
Where in Denmark
- Odense University HospitalOdense, DenmarkTaking people
- Departement of Cardiology, Odense University HospitalOdense C, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Odense University Hospital
- Trial code
- NCT05614219
- Record updated
- 20 February 2026
- Original description
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.Read full original descriptionShow less
Can Biochemistry Interpretive Comments on Elevated Cholesterol Levels, Increase Referrals to Lipid Clinics and Detection Rate of Familial Hypercholesterolemia? A Step Wedge Cluster Randomized Controlled Trial.
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.
Inclusion: 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: Cholestasis (alcalic fosfatase > 105 U/L and GGT > 55 U/L) 14 days prior to LDL-C measuring; Dysregulated diabetes. Hba1C < 48; Kombined hyperlipidiemia TG > 4 mmol/L; Nefrotic syndrome: proteinuria > 3 g/L and s-albumin < 30 g/l; Pregnancy and Secondary dyslipidemia; Dysregulated hypothyreosis. Elevated TSH; Pharmacological induced hyperlipidimia.