NCT06634160招募中不适用
Assessment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) Prevalence in Patients with Heterozygous Familial Hypercholesterolemia (HeFH): the STEATO-FH Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Presence of steatosis in HeFH patients
研究概览
简要总结
The main goal of the STEATO-FH study is to determine the prevalence of liver steatosis within the Heterozygous Familial Hypercholesterolemia patient population.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Presence of steatosis in HeFH patients
时间窗: 1 day
Presence of steatosis in HeFH patients assessed by Fibroscan® measurement of CAP (Controlled Attenuation Parameter) ≥ 275 dB/m (Berzigotti et al., 2021)
次要结局
- 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)
- Evaluate the link between the presence of hepatic steatosis or fibrosis and the risk of cardiovascular disease(12 months)
- Determine factors associated with the presence of steatosis or hepatic fibrosis(1 day)
研究者
研究点 (3)
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