Preventive Arterial Wall Phenotype in Subjects at Moderate Cardiovascular Risk Induced by Very Low-dose Fluvastatin/Valsartan Combination: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- gene Nrf2/NFE2L2
研究概览
简要总结
The study was designed to test whether short-term treatment with a very low-dose combination of fluvastatin and valsartan could induce improvement of endothelial function, arterial stiffness, vascular inflammation, oxidative stress and expression of protective genes in subjects with moderate cardiovascular risk.
详细描述
The largest population that suffers from cardiovascular events are subjects at moderate cardiovascular risk. However, no effective and safe preventive treatment is available for this population. This study aimed to investigate whether their arterial wall phenotype could be turned to a preventive direction by low-dose fluvastatin/valsartan combination (low-flu/val).
Twenty males at moderate cardiovascular risk (as classified by SCORE) were blindly randomised into the intervention group (n=10, low-flu/val: 10 mg/20mg) or control group (n=10, placebo). At inclusion and after 30 days of treatment, brachial flow-mediated dilatation (FMD), beta stiffness coefficient, carotid pulse wave velocity (c-PWV), carotid-femoral PWV, reactive hyperaemia index, high-sensitivity C-reactive protein (hs-CRP), interleukin 6, vascular cell adhesion molecule 1, total antioxidant status and expression of several protective genes (SIRT1, mTOR, NF-κB1, NFE2L2, PRKAA1) were followed.
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
- 40 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •moderate cardiovascular risk according to Systematic Coronary Risk Estimation (SCORE) risk charts of the European Society of Cardiology
- •aged between 40 and 55 years
排除标准
- •diabetes mellitus
- •manifest peripheral artery disease or carotid artery disease
- •acute infection
- •chronic diseases
- •present therapy with fluvastatin and/or valsartan
研究组 & 干预措施
intervention group
received fluvastatin 10 mg and valsartan 20 mg (low-flu/val) for 30 days
干预措施: fluvastatin 10 mg and valsartan 20 mg (Drug)
control group
received placebo for 30 days
干预措施: placebo (Drug)
结局指标
主要结局
gene Nrf2/NFE2L2
时间窗: 30 days
Hs00975961_g1
gene AMPK/PRKAA1
时间窗: 30 days
Hs01562315_m1
brachial flow-mediated dilatation (FMD)
时间窗: 30 days
FMD measured by ultrasound on right brachial artery (as result of reactive hyperaemia)
reactive hyperaemia index (RHI)
时间窗: 30 days
RHI measured by Endopat device
gene mTOR
时间窗: 30 days
Hs00234522_m1
beta stiffness coefficient
时间窗: 30 days
assessed by ultrasound employing e-Tracking on right common carotid artery
gene NF-kB1
时间窗: 30 days
Hs00765730_m1
carotid pulse wave velocity (c-PWV)
时间窗: 30 days
assessed by ultrasound employing e-Tracking on right common carotid artery
carotid-femoral PWV (cf-PWV)
时间窗: 30 days
cf-PWV measured by Sphygmocor device
high-sensitivity C-reactive protein (hs-CRP)
时间窗: 30 days
inflammatory marker
interleukin 6 (IL-6)
时间窗: 30 days
inflammatory marker
vascular cell adhesion molecule 1 (VCAM1)
时间窗: 30 days
inflammatory marker
total antioxidant status (TAS)
时间窗: 30 days
marker of oxidative stress
gene SIRT1
时间窗: 30 days
Hs01009006_m1
次要结局
- reactive hyperaemia index (RHI)(10 weeks after treatment completion)
- brachial flow-mediated dilatation (FMD)(10 weeks after treatment completion)
- beta stiffness coefficient(10 weeks after treatment completion)
- carotid pulse wave velocity (c-PWV)(10 weeks after treatment completion)
- carotid-femoral PWV (cf-PWV)(10 weeks after treatment completion)
研究者
Martina Turk Veselič
Medical Doctor
University Medical Centre Ljubljana