Improving detection of familial hypercholesterolemia through lab comments on cholesterol levels
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 2 sites (Odense, Funen and 1 other locations) |
| Trial ID | NCT05614219 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals referred to lipid clinics in Southern Denmark with specific LDL-C levels based on their age.
Not a fit: Patients who are pregnant or have secondary dyslipidemia or other specific medical conditions may not benefit from this study.
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 performed: Other studies have shown success in improving detection rates for similar conditions through systematic screening and interpretive comments, indicating a promising approach.
Eligibility criteria
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 this trial is running
Odense, Funen and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.