Improving Arterial Wall Characteristics in Patients After Myocardial Infarction With a Very Low Dose of Fluvastatin and Valsartan: Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- brachial flow mediated dilatation (FMD)
研究概览
简要总结
The concept of improving arterial wall characteristics by treatment with a very low-dose combination of fluvastatin and valsartan (low-flu/val) in stable, post-myocardial infarction (MI) patients was tested. The parameters of endothelial function (flow mediated dilatation (FMD), reactive hyperemia index) and arterial stiffness (carotid-femoral pulse wave velocity (cf-PWV), local carotid PWV and β-stiffness coefficient) were measured before and after 30 days of treatment, and the residual effect was assessed 10 weeks later. So the investigators explored whether low-flu/val added "on-top-of" optimal therapy could improve endothelial function and arterial stiffness in post-MI patients. Since these improved parameters are well-known predictors of future coronary events, such treatment could decrease cardiovascular risk.
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
- — 至 55 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •history of MI in the last 0.5 to 5 years
- •aged under 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
Treatment group
20 participants received low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val) per orally once daily for 30 days.
干预措施: low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val) (Drug)
Control group
16 participants received placebo per orally once daily for 30 days.
干预措施: placebo (Drug)
结局指标
主要结局
brachial flow mediated dilatation (FMD)
时间窗: 30 days
ultrasonographically measured flow mediated dilatation of brachial artery
carotid pulse wave velocity (c-PWV)
时间窗: 30 days
ultrasonographically measured pulse wave velocity of carotid artery
β-stiffness coefficient
时间窗: 30 days
ultrasonographically measured β-stiffness coefficient of carotid artery
carotid-femoral pulse wave velocity (cf-PWV)
时间窗: 30 days
carotid-femoral pulse wave velocity measured by Sphygmocor
reactive hyperemia index (RHI)
时间窗: 30 days
reactive hyperemia index measured by an Endopat device
次要结局
- brachial flow mediated dilatation (FMD)(10 weeks after termination of intervention)
- carotid pulse wave velocity (c-PWV)(10 weeks after termination of intervention)
- β-stiffness coefficient(10 weeks after termination of intervention)
- carotid-femoral pulse wave velocity (cf-PWV)(10 weeks after termination of intervention)
- reactive hyperemia index (RHI)(10 weeks after termination of intervention)
研究者
Martina Turk Veselič
Principal Investigator, M.D.
University Medical Centre Ljubljana