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Not yet recruitingNCT05825612Updated Apr 24, 2023

EPIRUS FH Reverse Cascade Screening

An observational study in Familial Hypercholesterolemia, sponsored by Hellenic Atherosclerosis Society. Not yet recruiting. Open to participants aged 4 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-24.

Sponsored by Hellenic Atherosclerosis Society · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
4 Years to 16 Years
Sex
All
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Study summary

Familial hypercholesterolemia (FH) is the most common inherited metabolic disorder resulting in marked elevations in low-density lipoprotein cholesterol (LDL-C). If left untreated, lifelong exposure to elevated LDL-C leads to a substantially increased risk of premature cardiovascular disease as compared to the general population. Although FH adverse cardiovascular outcomes are potentially preventable through early identification of FH individuals and initiation of effective treatment, available evidence shows that FH is under-diagnosed and under-treated.

Childhood is the optimal period for FH screening, because due to minimal dietary and hormonal influences, LDL-C levels reflect predominantly the genetic component in children and are well suited to discriminate FH from other causes of elevated LDL-C. If FH remains untreated in this latent stage of the disease, individuals show a 10-fold increase of cardiovascular risk during early and middle adulthood. In this context, an effective approach for detecting FH would be a screening during childhood or in young adolescents in combination with reverse cascade screening of first-degree relatives of FH individuals.

EPIRUS-FH registry is a model program of reverse cascade screening for FH in children and adolescents in Northwest Greece that aims to increase public and physician awareness, strengthen the national registry of familial hypercholesterolemia (HELLAS-FH) and constitute the core for a national FH registry in children and adolescents in Greece.

02

Conditions studied

  • Familial Hypercholesterolemia

Keywords

  • children
  • adolescents
  • reverse cascade screening
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In context

Hyperlipoproteinemia Type II

245 studies on the registry are indexed under Hyperlipoproteinemia Type II; 52 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 743 across 66 observational studies indexed under Hyperlipoproteinemia Type II.

Browse Hyperlipoproteinemia Type II studies →

Lead sponsor

Hellenic Atherosclerosis Society is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients genetically diagnosed with familial hypercholesterolemia (FH). Non-affected (non-FH) individuals as healthy controls.

Inclusion criteria

  • LDL-C >160 mg/dL on two seperate measurements 3 months apart
  • LDL-C >130 mg/dL + family history of premature coronary artery disease or hypercholesterolemia in one parent
  • Children and adolescents on cholesterol-lowering medication

Exclusion criteria

Exclusion Criteria:

  • Refusal to sign the consent form and disagreement with the terms of participation.
  • Any clinically significant disorder recognized at the time of the preliminary assessment, which in the judgment of the investigator would disqualify patient's participation in the study.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Heterozygous Familial Hypercholesterolemia

    Children and adolescents with Heterozygous Familial Hypercholesterolemia.

  • Homozygous Familial Hypercholesterolemia

    Children and adolescents with Homozygous Familial Hypercholesterolemia.

  • Unaffected (non-FH) individuals

    Children and adolescents not carrying the investigated FH mutations

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What researchers measure

Primary outcomes

  1. Diagnosis of Familial Hypercholesterolemia

    Type of FH (Heterozygous FH, Homozygous FH). In the case of genetic diagnosis, what gene was affected (LDL receptor, Apolipoprotein B, PCSK9, LDLRAP1, other to be specified). Age at diagnosis of FH.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05825612
Lead sponsor
Hellenic Atherosclerosis Society
Responsible party
Sponsor
First posted
Apr 24, 2023
Start date
May 2023 (estimated)
Primary completion
May 2033 (estimated)
Completion
May 2033 (estimated)
Last update
Apr 24, 2023

Study contacts

Haralampos Milionis
Contact
hmilioni@uoi.gr
+302651099736
Fotios Barkas
Contact
f.barkas@uoi.gr
+306936636376

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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