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Search / Trial NCT05614219

Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.

Launched by ODENSE UNIVERSITY HOSPITAL · Nov 10, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Familial Hypercholesterolemia Biochemistry Interpretive Comment Low Density Lipoprotein Cholesterol Levels Screening

ClinConnect Summary

This clinical trial, called "Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection," is focused on improving the diagnosis of familial hypercholesterolemia, a common inherited condition that leads to high cholesterol levels. In Denmark, many people with this condition remain undiagnosed, with only 15% of potential patients identified. The study aims to see if adding a special comment to blood test results that show high levels of LDL cholesterol (often referred to as "bad" cholesterol) can encourage doctors to refer more patients to specialized lipid clinics. The trial will run for a year and will gradually implement this comment across different laboratories in Southern Denmark.

To participate, patients must be referred to the lipid clinics and meet certain criteria based on their cholesterol levels: those under 40 should have an LDL-C level below 4 mmol/L, while those over 40 should have it above 5 mmol/L. Some individuals will not be eligible, such as pregnant women or those with certain health conditions affecting cholesterol levels. Participants can expect to help researchers understand whether this new approach can lead to more accurate diagnoses and better care for people with familial hypercholesterolemia.

Gender

ALL

Eligibility criteria

  • 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 over the age of 40.
  • 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

About Odense University Hospital

Odense University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital is committed to enhancing patient outcomes and fostering collaboration among multidisciplinary teams. With a focus on translating scientific discoveries into practical applications, Odense University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous trials across various medical fields, ensuring adherence to the highest ethical and regulatory standards. Through these efforts, the hospital aims to contribute significantly to the global body of medical knowledge and improve the quality of care for patients both locally and internationally.

Locations

Odense, Funen, Denmark

Odense C, , Denmark

Patients applied

0 patients applied

Trial Officials

Finn Lund Henriksen, Ph.d.

Principal Investigator

Departement of Cardiology, Odense University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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