Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05614219

Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.

Led by Odense University Hospital · Updated on 2026-02-20

2000

Participants Needed

2

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients referred to the lipid clinics of Southern Denmark
  • LDL-C 24 4 mmol/L in persons under 40 years old
  • LDL-C 25 5 mmol/L in persons 40 years or older
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Secondary dyslipidemia including:
  • Dysregulated diabetes with HbA1c C 48
  • Dysregulated hypothyroidism with elevated TSH
  • Combined hyperlipidemia with triglycerides > 4 mmol/L
  • Nephrotic syndrome with proteinuria > 3 g/L and serum albumin < 30 g/L
  • Cholestasis with alkaline phosphatase > 105 U/L and GGT > 55 U/L within 14 days prior to LDL-C measurement
  • Drug-induced hyperlipidemia

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Odense University Hospital

Odense, Funen, Denmark, 5000

Actively Recruiting

2

Departement of Cardiology, Odense University Hospital

Odense C, Denmark, 5000

Actively Recruiting

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Research Team

J

Jakob Knold, MD

CONTACT

F

Finn Lund Henriksen, Ph.d.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SCREENING

Number of Arms

2

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