Metformin Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease:A Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Left ventricular mass.
研究概览
简要总结
Cardiovascular disease is the most common cause of death in the world. Most of the attention in treating ischemic heart disease (IHD) is understandably directed toward treating coronary artery disease. However there are other treatable culprits in these patients.
Left ventricular hypertrophy (LVH) is widespread in IHD patients, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel cor-onary disease or impaired LV function.
Metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes. In the UKPDS (United Kingdom Prospective Diabetes Study), metformin was associated with a 39% lower risk of myocardial infarction compared with conventional therapy. Metformin also offered dual benefits of improving vascular function and lessening ischemia in nondiabetic patients.
Hence, the main aim of this study was to assess whether metformin could regress LVM in patients with IHD. The secondary aim was to assess the effect of metformin on LV volumes and endothelial function in this patient group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They had to have normal glucose tolerance.
- •They had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction.
- •They were required to have an office BP < 130/80 mm Hg
- •The presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index [LVMI] > 115 g/m2 for men and > 95 g/m2 for women).
排除标准
- •They were currently prescribed metformin.
- •They had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent.
- •Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.
研究组 & 干预措施
Metformin group
In this group, metformin 0.5 three times daily for one year.
干预措施: Metformin (Drug)
Placebo group
In this group, placebo will be given twice daily for one year.
干预措施: placebo (Drug)
结局指标
主要结局
Left ventricular mass.
时间窗: one year
We will measure left ventricular mass before and after metformin intervention with cardiac magnetic resonance.
次要结局
- Left ventricular volume and endothelial function.(one year)
研究者
Xiang Guang-da
Director of Endocrinol Dept.
Wuhan General Hospital of Guangzhou Military Command