Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: 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

Treatments Being Tested

OTHER

Biochemistry 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.

Locations (2)

Odense University Hospital
Odense, Funen, Denmark
Departement of Cardiology, Odense University Hospital
Odense C, Denmark