Actively Recruiting
Assessment of Metabolic Dysfunction-associated Steatotic Liver Disease in Patients With Heterozygous Familial Hypercholesterolemia: the STEATO-FH Study
Led by Nantes University Hospital · Updated on 2025-02-06
200
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
U
University Hospital, Angers
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to find out how common liver steatosis is in patients with heterozygous familial hypercholesterolemia (HeFH), a genetic condition affecting cholesterol levels. The study focuses on the prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) among this group. Researchers are also exploring connections between liver health and cardiovascular risk factors. Participants will undergo a Fibroscan, a non-invasive ultrasound-based test to measure liver steatosis after fasting for at least three hours. In addition, biological samples will be collected for further analysis. The study will measure coronary calcium scores and evaluate various health factors such as diabetes presence, cholesterol levels, body measurements, and genetic mutations related to liver and heart health. During the study, participants will be assessed at their hospital consultations, including Fibroscan testing and blood sample collection. Researchers will gather data on liver fat, fibrosis, diabetes, and cardiovascular risk over time. The main outcome is the presence of liver steatosis, with secondary outcomes including fibrosis prevalence and links to metabolic and cardiovascular factors. The study period extends to 2028, allowing for long-term observations.
CONDITIONS
Brief Title
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 35 or over
- Consultation at Nantes, Rennes or Angers University Hospital during the inclusion period
- Diagnosis of familial hypercholesterolemia confirmed by a genetic variant classified as ACMG classes 4 or 5 on LDLR, APOB, or PCSK9
- Patient does not object to inclusion in the study
You will not qualify if you...
- Minors, adults under guardianship, curatorship, or safeguard of justice
- Pregnant or breastfeeding individuals
- Active viral hepatitis
- Hemochromatosis
- Other genetic or autoimmune hepatitis
- Current treatment with drugs likely to cause hepatic steatosis such as amiodarone, carbamazepine, tamoxifen, valproate, clozapine, or anti-retrovirals
- Current oral corticosteroid therapy unless dose has been stable for at least 3 months
- Pathological alcohol consumption (60 g/day or more in men, 50 g/day or more in women)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo non-invasive assessments including Fibroscan to evaluate liver steatosis and fibrosis, coronary calcium scoring, and biological sample collection.
1 visit (in-person)
Duration - 12 months
Participants are observed to evaluate cardiovascular risk associated with liver conditions over time.
Follow-up visits as per routine care
Trial Site Locations
Total: 3 locations
1
CHU angers
Angers, France, 49933
Not Yet Recruiting
2
CHU Nantes
Nantes, France
Actively Recruiting
3
Rennes University Hospital
Rennes, France, 35033
Not Yet Recruiting
Research Team
S
Sarra SMATI
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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