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临床试验/EUCTR2014-003189-26-GB
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

发起方
niversity of Dundee/NHS Tayside

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