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临床试验/ISRCTN14780645
ISRCTN14780645已完成未知

Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial: a large simple randomised trial of combined cholesterol modification and blood pressure lowering in middle aged people at average risk

Hamilton Health Sciences Corporation (Canada)0 个研究点目标入组 11,000 人开始时间: 2008年11月12日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
11,000
研究概览入排标准研究者记录与标识符相似试验

研究概览

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •1. Women aged greater than or equal to 60 years with at least two additional risk factors and, women aged greater than or equal to 65 years and men greater than or equal to 55 years with at least one additional risk factor
  • •2. Suggested CV risk factors for trial eligibility:
  • •2.1. Waist/hip ratio greater than 0.90 in men and greater than 0.85 in women
  • •2.2. History of current or recent smoking (regular tobacco use within 5 years)
  • •2.3. Low HDL cholesterol (for example, HDL cholesterol less than 1.0 mmol/L [40 mg/dl] in men and less than 1.3 mmol/L [50 mg/dl] in women)
  • •2.4. Dysglycaemia (impaired fasting glucose [IFG], impaired glucose tolerance [IGT] or uncomplicated diabetes treated by diet only)
  • •2.5. Renal dysfunction:
  • •2.5.1. Microalbuminuria
  • •2.5.2. Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m^2 or serum creatinine greater than 124 µmol/L (1.4 mg/dL) (unless participant has proteinuria or blood pressure above 130/80 mmHg)
  • •2.6. Family history of premature coronary heart disease (CHD) in first degree relatives (age less than 55 years in men or less than 65 years in women)
  • •3. Provision of informed consent

排除标准

  • •1. Documented clinically manifest atherothrombotic CVD
  • •2. Clear indication for statin and/or angiotensin-receptor blocker (ARB) or angiotensin converting enzyme (ACE) inhibitor and/or thiazide diuretic therapy, as determined by the subject's own local physician
  • •3. Clear contraindication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy, as determined by the subject's own local physician
  • •4. Symptomatic hypotension
  • •5. Chronic liver disease (i.e. cirrhosis or persistent hepatitis) or abnormal liver function, i.e. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 x upper limit of normal (ULN)
  • •6. Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine kinase (CK) greater than 3 x ULN
  • •7. Moderate renal dysfunction (serum creatinine greater than 180 µmol/L [2.0 mg/dl] or eGFR less than 45 ml/min/1.73 m^2)
  • •8. Mild renal dysfunction (eGFR less than 60 ml/min/1.73 m^2) and proteinuria or blood pressure above 130/80 mmHg
  • •9. Concurrent treatment with cyclosporin or a condition likely to result in organ transplantation and the need for cyclosporin
  • •10. Concurrent treatment with a statin or a fibrate (subjects on cholesterol-lowering diets or drugs other than statins or fibrates can still be included)
  • •11. Concurrent treatment with an angiotensin receptor blocker, ACE inhibitor, or a thiazide diuretic
  • •12. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial
  • •13. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures
  • •14. Concurrent use of an experimental pharmacological agent

研究者

发起方
Hamilton Health Sciences Corporation (Canada)

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