Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.

Recruiting now · Not applicable

Conditions studied: Familial Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT05614219

Run by

Odense University Hospital

People needed

2000

Starts

2023-12-01

Expected to finish

2027-05-01

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Odense University Hospital — Odense, Funen, Denmark (enrolling)
• Departement of Cardiology, Odense University Hospital — Odense C, Denmark (enrolling)

Full record on ClinicalTrials.gov

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