The Role of Neuroinflammation in Hypertension.Minocycline for Resistant Hypertension: a Randomized Double Blind Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of change in central and peripheral inflammation
研究概览
简要总结
To demonstrate that in patients with resistant hypertension oral treatment with minocycline via inhibition of central immune cell activation and inflammation results in reduced central sympathetic outflow and concomitant lowering of BP.
详细描述
This is a randomized, double-blind, placebo controlled, parallel group design study aiming to compare the effects of minocycline 100mg twice daily vs matched placebo for 12 weeks on ambulatory BP and the parameters of sympathetic and immune activation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged: 45 -65 years
- •Signed informed consent
- •Clinical diagnosis of Resistant Hypertension
- •Daytime systolic ambulatory BP >135mmHg.
排除标准
- •eGFR of <45 mL/min/1.73m2
- •History of myocardial infarction (MI) or any cardiovascular event within 3 months of screening period, clinically significant AV conduction disturbances and/or arrhythmias,
- •current of past history of heart failure (LVEF ≤40%)
- •psychotropic agents, antidepressants and NSAIDS
- •alcohol consumption of >3 standard drinks.
- •known hypersensitivity or contraindication to minocycline or other tetracyclines.
研究组 & 干预措施
Minocycline Group
Subjects will be randomized to receive Minocycline 100mg twice daily
干预措施: Minocycline (Drug)
Placebo Group
Subjects will be randomized to receive placebo.
干预措施: Minocycline (Drug)
结局指标
主要结局
Assessment of change in central and peripheral inflammation
时间窗: 12 weeks
FDG PET
The difference in the daytime systolic blood pressure between groups after respective treatment.
时间窗: 12 weeks
Office and ambulatory blood pressures
次要结局
- Change in muscle sympathetic nerve activity(12 weeks)
- Change in central Blood Pressure(12 weeks)
研究者
Dr Markus Schlaich
Professor
Royal Perth Hospital