Improving detection of familial hypercholesterolemia through lab comments on cholesterol levels
Official title: Can Biochemistry Interpretive Comments on Elevated Cholesterol Levels, Increase Referrals to Lipid Clinics and Detection Rate of Familial Hypercholesterolemia? A Step Wedge Cluster Randomized Controlled Trial.
Run by Odense University Hospital · NCT05614219 · Data updated 2026-11-12
This study is testing if adding helpful comments about high cholesterol levels in lab reports can lead to more people being referred for familial hypercholesterolemia diagnosis and treatment in Southern Denmark.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 2 sites (Odense, Funen and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT05614219 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals referred to lipid clinics in Southern Denmark with specific LDL-C levels based on their age.
✕Probably not a fit
Patients who are pregnant or have secondary dyslipidemia or other specific medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to enhance the detection of familial hypercholesterolemia (FH) by implementing a biochemistry interpretive comment on elevated LDL-C levels in Southern Denmark. It will utilize a step wedge cluster randomized controlled trial design to evaluate whether this comment increases referrals to lipid clinics and subsequently leads to more diagnoses of FH. The study will run for 52 weeks, gradually introducing the interpretive comment across different laboratories in the region. By addressing the underdiagnosis of FH, the project seeks to improve cardiovascular health outcomes through timely treatment.
Why it matters
Potential benefit: If successful, this approach could significantly increase the early diagnosis and treatment of familial hypercholesterolemia, reducing the risk of cardiovascular diseases.
How similar studies have gone: Other studies have shown success in improving detection rates for similar conditions through systematic screening and interpretive comments, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion 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 ≥ 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's running
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Odense University Hospital
Odense, Funen, Denmark Recruiting -
Departement of Cardiology, Odense University Hospital
Odense C, Denmark Recruiting
Study contacts
- Principal investigator: Finn Lund Henriksen, Ph.d. — Departement of Cardiology, Odense University Hospital
- Study coordinator: Jakob Knold, MD
- Email: jakobknold@rsyd.dk
- Phone: 004541278928
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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ORIGIN-FH: Newborn screening to detect familial high cholesterol
This project will test a genetic cheek swab of parents plus blood screening of newborns to find familial high cholesterol in babies born to parents with familial hypercholesterolemia.
-
Registry for hereditary cardiovascular diseases in Brazil
This study is trying to create a registry of Brazilian patients with hereditary heart diseases to see how common certain genetic changes are in people with these conditions.
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Exploring YOLT-101 for treating Familial Hypercholesterolemia
This study is testing a new treatment called YOLT-101 to see if it can safely lower cholesterol levels in people with familial hypercholesterolemia.
-
Atlantic program to optimize cholesterol-lowering care
This program will try coordinated outreach with primary care providers to lower LDL-C in people with familial hypercholesterolemia or LDL-C ≥160 mg/dL.
-
Observational study on genetic lipid disorders in Italy
This study looks at families with high cholesterol to see how genetics affect their condition and treatment, using information gathered during regular doctor visits.
-
Comparing direct and indirect methods for screening family members at risk for genetic conditions
This study is testing two ways to reach out to family members at risk for Long QT Syndrome and Familial Hypercholesterolemia to see which method helps them get screened better, while also offering free genetic testing and counseling.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.