Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.
Recruiting · NCT05614219 · Interventional (participants receive a specific treatment) · Lead sponsor: Odense University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
Where it is running
2 locations listed.
- Departement of Cardiology, Odense University Hospital - Odense C, Denmark
- Odense University Hospital - Odense, Funen, Denmark