Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Assessment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) Prevalence in Patients With Heterozygous Familial Hypercholesterolemia (HeFH): the STEATO-FH Study
Nantes University Hospital
200 participants
Jan 30, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria8
- 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)
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Interventions
Evaluation of the prevalence of steatosis by measuring ultrasound attenuation with Fibroscan® (non-invasive method, at a distance from a meal (3h fasting)).
20 mL whole blood sample
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06634160