RecruitingNot ApplicableNCT05614219

Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.

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.

Sponsor

Odense University Hospital

Enrollment

2,000 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Familial Hypercholesterolemia

Summary

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria7

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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Interventions

OTHERBiochemistry interpretive comment on elevated LDL-C levels

The interpretive comment on LDL-C will encourage for excluding secondary dyslipidemia (measuring Hba1C, TSH and checking current drugs and talk about diet). If secondary dyslipidemia ca be excluded we encourage to referral to lipid clinic. Familial hypercholesterolemia should be suspected if LDL-C ≥ 4 mmol/L in persons under the age of 40, or LDL-C ≥ 5 mmol/L in persons ≥ 40. The biochemistry interpretive comment will thus be released to the referring physician if the blood sample meet the criteria above. We advice that in pregnant women to control elevated LDL-C after childbirth.