NCT06634160

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jan 2025Jan 2028

First Submitted

Initial submission to the registry

October 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

October 4, 2024

Last Update Submit

February 5, 2025

Conditions

Heterozygous Familial Hypercholesterolemia

Keywords

MASLDHeterozygous Familial Hypercholesterolemiasteatosisfibrosis

Outcome Measures

Primary Outcomes (1)

  • Presence of steatosis in HeFH patients

    Presence of steatosis in HeFH patients assessed by Fibroscan® measurement of CAP (Controlled Attenuation Parameter) ≥ 275 dB/m (Berzigotti et al., 2021)

    1 day

Secondary Outcomes (7)

  • Establish the prevalence of hepatic fibrosis

    1 day

  • Evaluate the prevalence of diabetes among HeFH patients, according to the presence or absence of steatosis or fibrosis

    1 day

  • Evaluate the association between anthropometric measures (weight, height, waist circumference, and calculated BMI) and the presence of hepatic steatosis or fibrosis.

    1 day

  • Evaluate the association between LDL-cholesterol and time of exposure to elevated LDL-cholesterol (Gallo et al. J Clin Lipidol 2017) with the prevalence of steatosis or fibrosis

    1 day

  • Evaluate the proportion of patients with hepatic steatosis or fibrosis according to the nature of the genetic mutation

    1 day

  • +2 more secondary outcomes

Other Outcomes (1)

  • Identify blood biomarkers associated with hepatic steatosis and fibrosis

    1 day

Study Arms (1)

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.

Diagnostic Test: FibroscanOther: Sample collection

Interventions

FibroscanDIAGNOSTIC_TEST

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

Study population
Sample collectionOTHER

20 mL whole blood sample

Study population

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible patients are those with definite familial hypercholesterolemia (genetic variant, ACMG classes 4 \& 5 on LDLR, APOB or PCSK9), consulting during the inclusion period and age ≥ 35 years.

You may qualify if:

  • Patient aged 35 or over
  • With a diagnosis of familial hypercholesterolemia defined by the presence of a genetic variant, ACMG classes 4 \& 5 on LDLR, APOB or PCSK9

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU angers

Angers, 49933, France

NOT YET RECRUITING

CHU Nantes

Nantes, France

RECRUITING

Rennes University Hospital

Rennes, 35033, France

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Two tubes of 10 mL blood each will be collected per patient in the study.

MeSH Terms

Conditions

Fatty LiverFibrosis

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Sarra SMATI

CONTACT

02 53 48 27 19sarra.grangeon@chu-nantes.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 9, 2024

Study Start

January 30, 2025

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2028

Last Updated

February 6, 2025

Record last verified: 2025-02

Locations

FR(3)