Assessing liver fat in patients with a specific cholesterol condition
Assessment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) Prevalence in Patients With Heterozygous Familial Hypercholesterolemia (HeFH): the STEATO-FH Study
This study is testing how common liver fat is in people with a specific cholesterol condition called heterozygous familial hypercholesterolemia, using a non-invasive method to measure it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 3 sites (Angers and 2 other locations) |
| Trial ID | NCT06634160 on ClinicalTrials.gov |
What this trial studies
This study aims to determine how common liver steatosis is among patients diagnosed with heterozygous familial hypercholesterolemia. Researchers will non-invasively measure liver fat using Fibroscan and evaluate coronary calcium scores. Additionally, biological samples will be collected for further analysis. The study will involve patients aged 35 and older who are being treated at specific university hospitals in France.
Who should consider this trial
Good fit: Ideal candidates are patients aged 35 or older with a confirmed diagnosis of heterozygous familial hypercholesterolemia.
Not a fit: Patients who are minors, pregnant, or have active liver diseases or certain medication regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of liver health in patients with familial hypercholesterolemia, potentially leading to better management strategies.
How similar studies have performed: While studies on liver conditions in hypercholesterolemia exist, this specific approach focusing on steatosis prevalence is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Angers and 2 other locations
- CHU angers — Angers, France (Not_yet_recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- Rennes University Hospital — Rennes, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Sarra SMATI
- Email: sarra.grangeon@chu-nantes.fr
- Phone: 02 53 48 27 19
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.