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

Plain Language Summary

Simplified for easier understanding

This Danish study tests whether adding an interpretive comment to lab results flagging very high LDL cholesterol (bad cholesterol) nudges doctors to consider whether their patient might have familial hypercholesterolemia (FH) — a genetic condition causing dangerously high cholesterol that often goes undiagnosed. Earlier detection means earlier treatment and reduced heart disease risk. You may be eligible if: - You are 18 or older and have been referred to a lipid clinic in Southern Denmark - Your LDL cholesterol is 4 mmol/L or above (if under 40 years old) or 5 mmol/L or above (if 40 or older) You may NOT be eligible if: - You are pregnant - You have secondary causes of high cholesterol, such as uncontrolled diabetes, underactive thyroid (hypothyroidism), very high triglycerides, nephrotic syndrome, liver disease, or drug-induced hyperlipidaemia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.