NCT05614219Recruiting
Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.
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.
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 27 Oct 2022
- Start date
- 1 Dec 2023
- Primary completion date
- 1 May 2027
- Lead sponsor
- Odense University Hospital
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05614219
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From 1 Dec 2023 to the primary completion date, 1 May 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cholestasis (alcalic fosfatase \> 105 U/L and GGT \> 55 U/L) 14 days prior to LDL-C measuring
Lab values
- Dysregulated diabetes. Hba1C \< 48
- Kombined hyperlipidiemia TG \> 4 mmol/L
- Nefrotic syndrome: proteinuria \> 3 g/L and s-albumin \< 30 g/l
Other
- Pregnancy and Secondary dyslipidemia
- Dysregulated hypothyreosis. Elevated TSH.
- Pharmacological induced hyperlipidimia
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
| Departement of Cardiology, Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.