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NCT06634160 | NOT YET RECRUITING | Heterozygous Familial Hypercholesterolemia

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

Nantes University Hospital

Brief Summary:

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

Condition or disease

Heterozygous Familial Hypercholesterolemia

Intervention/treatment

Fibroscan

Sample collection

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 200 participants
Official Title : Assessment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) Prevalence in Patients With Heterozygous Familial Hypercholesterolemia (HeFH): the STEATO-FH Study
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2026-12-01
Estimated Study Completion Date : 2027-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia

Location Details

NCT06634160

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

CHU angers

Angers, France, 49933

Not yet recruiting

France,

CHU Nantes

Nantes, France,

Not yet recruiting

France,

Rennes University Hospital

Rennes, France, 35033