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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high LDL cholesterol (a type of blood fat) who are referred to the lipid clinics of Southern Denmark.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- High LDL-C: 4 mmol/L (155 mg/dL) or more if under 40 years, 5 mmol/L or more if 40 years or older.
- Biomarker or test result
- LDL-C of 4 mmol/L (155 mg/dL) or more (under 40 years) or 5 mmol/L or more (40 years and older).
Main reasons for not taking part
- Pregnancy
- Secondary dyslipidemia (high blood fats caused by another condition)
- Dysregulated diabetes
- Dysregulated hypothyroidism (elevated TSH)
- Nephrotic syndrome or cholestasis
Read by machine on 12 November 2026.
Where in Denmark
- Odense University HospitalOdense, DenmarkContact: Jakob Knold, M.d.Taking people
- Departement of Cardiology, Odense University HospitalOdense C, DenmarkContact: Finn Lund Henriksen, MDTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.