EUCTR2014-003189-26-GB进行中(未招募)1 期
Metformin and its Effects on Myocardial Dimension and Left ventricular hypertrophy in normotensive patients with Coronary Artery Disease. - The MET REMODEL Study
niversity of Dundee/NHS Tayside0 个研究点目标入组 68 人开始时间: 2014年10月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) Participant is willing and able to give informed consent for participation in the study
- •2) Aged 18 years or over
- •3) Documented Ischaemic Heart Disease: either angio-graphically documented coronary artery disease or a previous history of myocardial infarction/angina.
- •4) Have screening echocardiography based diagnosis of LVH based on ASE criteria (males >115g/m2, females >95g/m2)
- •5) Fasting insulin resistance index = 2.7 at screening
- •6) Clinic Blood pressure < 140/85 mm Hg or 24hr BP <135/85 daytime average in screening
- •7)Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •1) Severe cognitive impairment precluding written informed consent
- •2) Type 1 or 2 Diabetes mellitus
- •3) Chronic Heart Failure as evidenced by an echocardiogram or a diagnosis of CHF
- •4) Left Ventricular Ejection Fraction <45% on echocardiography screening
- •5) Contraindications to cardiac MRI (pacemakers, claustrophobia, metal implants, history of penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
- •6) Malignancy (receiving active treatment) or other life threatening diseases
- •7) renal disease; CKD class 3B or worse (to exclude risk of lactic acidosis)
- •8) Pregnancy and lactating women
- •9) Any other considered by a study physician to be inappropriate for inclusion
- •10) Participants who have participated in any other clinical trial within the previous 30 days will be excluded.
研究者
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