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Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.

NCT05614219 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Familial Hypercholesterolemia

Interventions

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.

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Finn Lund Henriksen, Ph.d. · Departement of Cardiology, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2027-05-01
Completion
2027-05-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614219 on ClinicalTrials.gov