Relationships Between Plasma PCSK9 Levels, LDL-cholesterol Concentrations and Lipoprotein (a) Levels in Familial Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Impact of PCSK9 on LDL-C concentrations
研究概览
简要总结
Familial hypercholesterolemia (FH) is an autosomal codominant single gene disorder caused by mutations in the LDL receptor gene (LDLR) that disrupt the normal clearance of LDL particles from the plasma. Heterozygous patients (HeFH) present a two- to three-fold raise in plasma LDL-cholesterol (LDL-C) concentrations and coronary artery disease occurs earlier among HeFH carrying negative-receptor (NR) mutations as compared with HeFH subjects carrying defective-receptor (DR) variants. Proprotein convertase subtilisin/kexin type 9 (PCSK9) regulates LDL-C levels by binding to LDLR and by enhancing its intracellular degradation.
The objective of this study is to examine to what extent variations in LDL-C and Lipoprotein (Lp) (a) concentrations are related to PCSK9 levels in a large French-Canadian cohort of HeFH subjects.
The primary hypothesis is that that PCSK9 levels have a significant impact on LDL-C concentration variability and are associated with Lp(a) levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with familial hypercholesterolemia:
- •Aged between 18-65 years
- •Carrier of a mutation in the LDL receptor gene
- •Aged between 18-60 years
- •HDL-cholesterol > 1.1 mmol/L
- •Triglycerides < 1.7 mmol/L
- •Fasting blood glucose <6.1 mmol/L
- •Normal blood pressure (<130/85)
排除标准
- •Subjects with a previous history of cardiovascular disease
- •Subjects with Type 2 diabetes
- •Were pregnant or nursing;
- •Subjects with a history of cancer
- •Subjects with acute liver disease, hepatic dysfunction, or persistent elevations of serum transaminases
- •Subjects with a secondary hyperlipidemia due to any cause
- •History of alcohol or drug abuse within the past 2 years
- •hormonal treatment
- •Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
结局指标
主要结局
Impact of PCSK9 on LDL-C concentrations
时间窗: Week 1
次要结局
- Impact of PCSK9 on Lp(a) concentrations(Week 1)
研究者
Patrick Couture
MD, FRCP, PhD
Laval University