NCT04941599招募中2 期
2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 2-HOBA increases HDL cholesterol efflux capacity.
研究概览
简要总结
The Investigators will test the hypothesis that 2-HOBA will reduce modification of HDL and LDL and improve HDL function in humans with heterozygous FH. The Investigators plan to first study subjects with Familial Hypercholesterolemia (FH), treating them with 750 mg of 2-HOBA or placebo every 8 hours for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with heterozygous Familial Hypercholesterolemia.
排除标准
- •Myocardial infarction or stroke within the last 6 months
- •unstable angina, symptoms of angina within the last 3 months
- •NYHA class III or IV heart failure or LVEF < 30%
- •poorly controlled hypertension: SBP > 180 mm Hg or DBP > 110 mm Hg,
- •pregnancy,
- •evidence of a previous acute coronary syndrome,
- •current smokers,
- •individuals with Type 2 Diabetes Mellitus, obesity (BMI > 30),
- •hypertriglyceridemia (fasting TG > 250 mg/dl),
- •renal insufficiency (Cr > 1.8),
- •hepatic disease (aspartate aminotransferase(AST) or alanine aminotransferase (ALT) > 2x ULN),
- •hypothyroidism,
- •nephrotic syndrome,
- •rheumatoid arthritis,
- •systemic lupus erythematosus,
- •AIDS or HIV
- •history of malignancy of any organ in last 5 years.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo- three tabs TID (po) for 6 weeks.
干预措施: Placebo (Other)
2-Hydroxybenzylamine (2-HOBA)
Active Comparator
2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.
干预措施: 2-Hydroxybenzylamine (Drug)
结局指标
主要结局
2-HOBA increases HDL cholesterol efflux capacity.
时间窗: Baseline to week 6
Change in HDL cholesterol efflux capacity will be measured by macrophage cholesterol efflux assay.
次要结局
- 2-HOBA reduces modification of HDL by Isolevuglandin (Iso-LG).(Baseline to week 6)
- 2-HOBA reduces modification of HDL by malondialdehyde (MDA).(Baseline to week 6)
研究者
MacRae F. Linton, MD
Professor of Medicine and Pharmacology
Vanderbilt University Medical Center
研究点 (1)
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