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Recruiting Observational

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

NCT06634160 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-01-30
Last updated
2025-02-06

Condition(s) studied

Heterozygous Familial Hypercholesterolemia

Investigational drug(s) / intervention(s)

FibroscanSample collection

Fibroscan: Evaluation of the prevalence of steatosis by measuring ultrasound attenuation with Fibroscan® (non-invasive method, at a distance from a meal (3h fasting)).

Sample collection: 20 mL whole blood sample

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

Sex
ALL
Min age
35 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient aged 35 or over * Consultation at Nantes, Rennes or Angers University Hospital during the inclusion period * With a diagnosis of familial hypercholesterolemia defined by the presence of a genetic variant, ACMG classes 4 \& 5 on LDLR, APOB or PCSK9 * Patient not objecting to inclusion in study (no written objection) Exclusion Criteria: * Protected patients: minors, adults under guardianship, curatorship and/or safeguard of justice * Pregnant or breast-feeding * Active viral hepatitis * Hemochromatosis * Other genetic or autoimmune hepatitis * Current treatment with a drug likely to cause hepatic steatosis, including amiodarone, 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)

Primary outcome measure(s)

  • Presence of steatosis in HeFH patients — 1 day
    Presence of steatosis in HeFH patients assessed by Fibroscan® measurement of CAP (Controlled Attenuation Parameter) ≥ 275 dB/m (Berzigotti et al., 2021)

Trial sites (3)

FacilityCityRegionStatus
CHU angers Angers France Not Yet Recruiting
CHU Nantes Nantes France Recruiting
Rennes University Hospital Rennes France Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06634160 on ClinicalTrials.gov ↗ ← All trials in France