Assessment of the Prevalence of Steatotic Liver Disease Associated with Metabolic Dysfunction in Patients with Heterozygous Familial Hypercholesterolemia

Last updated: February 5, 2025
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Familial Hypercholesterolemia

Primary Biliary Cholangitis

Treatment

Sample collection

Fibroscan

Clinical Study ID

NCT06634160
RC24_0064
2024-A01647-40
  • Ages > 35
  • All Genders

Study Summary

The main goal of the STEATO-FH study is to determine the prevalence of liver steatosis within the Heterozygous Familial Hypercholesterolemia patient population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient aged 35 or over

  • Consultation at Nantes, Rennes or Angers University Hospital during the inclusionperiod

  • With a diagnosis of familial hypercholesterolemia defined by the presence of agenetic variant, ACMG classes 4 & 5 on LDLR, APOB or PCSK9

  • Patient not objecting to inclusion in study (no written objection)

Exclusion

Exclusion Criteria:

  • Protected patients: minors, adults under guardianship, curatorship and/or safeguardof justice

  • Pregnant or breast-feeding

  • Active viral hepatitis

  • Hemochromatosis

  • Other genetic or autoimmune hepatitis

  • Current treatment with a drug likely to cause hepatic steatosis, includingamiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals

  • Current oral corticosteroid therapy unless dose has been stable for ≥ 3 months

  • Current pathological alcohol consumption (≥ 60 g/day in men and ≥ 50 g/day in women)

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Sample collection
Phase:
Study Start date:
January 30, 2025
Estimated Completion Date:
January 30, 2028

Study Description

Investigators will include patients being followed for heterozygous familial hypercholesterolemia in their centers. The prevalence of hepatic steatosis will be studied non-invasively, using Fibroscan ®. In addition, coronary calcium score (CAC scores) will be evaluated and a biocollection will be performed.

Connect with a study center

  • CHU angers

    Angers, 49933
    France

    Site Not Available

  • CHU Nantes

    Nantes,
    France

    Active - Recruiting

  • Rennes University Hospital

    Rennes, 35033
    France

    Site Not Available

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