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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-30

Study Completion Date

2028-01-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Heterozygous Familial Hypercholesterolemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Study population

The study population must correspond to the research inclusion criteria. A fibroscan will be performed on each patient enrolled in the study. Each participant will also be offered a biological sample for an ancillary study.

Fibroscan

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type OTHER

20 mL whole blood sample

Interventions

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Fibroscan

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

Intervention Type DIAGNOSTIC_TEST

Sample collection

20 mL whole blood sample

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No