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NCT05614219
Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.
Conditions: Familial Hypercholesterolemia
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 2000
Sponsor: Odense University Hospital
Location: Denmark
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 Criteria
Inclusion Criteria:All referred patients to the lipid clinics of Southern DenmarkLDL-C < 4 mmol/L in persons under the age of 40.LDL-C > 5 mmol/L in persons over the age of 40.Exclusion Criteria:Pregnancy and Secondary dyslipidemiaDysregulated diabetes.
Hba1C < 48Dysregulated hypothyreosis.
Elevated TSH.Kombined hyperlipidiemia TG > 4 mmol/LNefrotic syndrome: proteinuria > 3 g/L and s-albumin < 30 g/lCholestasis (alcalic fosfatase > 105 U/L and GGT > 55 U/L) 14 days prior to LDL-C measuringPharmacological induced hyperlipidimia
Source: ClinicalTrials.gov (NCT05614219). StuddyBuddy aggregates publicly available trial information.