Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biochemistry interpretive comment on elevated LDL-C levels

Treatment groups

2,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators