NCT05614219 Familial Hypercholesterolemia Interpretive Comment - Nudging to Detection.
| NCT ID | NCT05614219 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Familial Hypercholesterolemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2023-12-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 ≥ 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
Contact & Investigator
Finn Lund Henriksen, Ph.d.
PRINCIPAL INVESTIGATOR
Departement of Cardiology, Odense University Hospital
Frequently Asked Questions
Who can join the NCT05614219 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Familial Hypercholesterolemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05614219 currently recruiting?
Yes, NCT05614219 is actively recruiting participants. Contact the research team at jakobknold@rsyd.dk for enrollment information.
Where is the NCT05614219 trial being conducted?
This trial is being conducted at Odense, Denmark, Odense C, Denmark.
Who is sponsoring the NCT05614219 clinical trial?
NCT05614219 is sponsored by Odense University Hospital. The principal investigator is Finn Lund Henriksen, Ph.d. at Departement of Cardiology, Odense University Hospital. The trial plans to enroll 2,000 participants.