Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Recruiting · NCT06634160 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nantes University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
FibroscanSample collection
What this trial is about
The main goal of the STEATO-FH study is to determine the prevalence of liver steatosis within the Heterozygous Familial Hypercholesterolemia patient population.
Who can take part
Age range
35 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
3 locations listed.
- CHU angers - Angers, France
- CHU Nantes - Nantes, France
- Rennes University Hospital - Rennes, France