EUCTR2007-001493-91-SE进行中（未招募）1 期
Heart Outcomes Prevention Evaluation (HOPE-3) - HOPE-3
Population Health Research Institute, McMaster University/Hamilton Health Sciences0 个研究点目标入组 11,000 人开始时间: 2007年6月15日最近更新:
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
- 11,000
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
- 性别
- All
入选标准
- •Women aged >60 years of age with at least two additional risk factors, and women = 65 years and men =55 years with at least one additional CV risk factor
- •Suggested CV risk factors for trial eligibility:
- •oWaist/hip ratio = 0.90 in men and = 0.85 in women
- •oHistory of current or recent smoking (regular tobacco use within 5 years)
- •oLow HDL cholesterol (for example, HDL cholesterol < 1.0 mmol/L [40 mg/dl] in men and <1.3 mmol/L [50 mg/dl] in women)
- •oDysglycemia (impaired fasting glucose [IFG], impaired glucose tolerance [IGT] or uncomplicated diabetes treated by diet only
- •oRenal dysfunction
- •Microalbuminuria
- •estimated GFR <60 ml/min or creatinine > 124 µmol/L (1.4 mg/dL)
- •oFamily history of premature CHD in first degree relatives (age < 55 years in men or <65 years in women)
- •Provision of informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Documented clinically manifest atherothrombotic CVD
- •Clear indication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy, as determined by the subject’s own local physician
- •Clear contraindication for statin and/or ARB or ACE inhibitor and/or thiazide diuretic therapy, as determined by the subject’s own local physician*
- •Symptomatic hypotension
- •Chronic liver disease (i.e. cirrhosis or persistent hepatitis) or abnormal liver function, i.e. ALT or AST > 3 x upper limit of normal [ULN]
- •Inflammatory muscle disease (such as dermatomyositis or polymyositis) or creatine kinase (CK) > 3 x ULN
- •Moderate renal dysfunction defined as serum creatinine > 180µmol/L (2.0 mg/dl) or eGFR <45 ml/min/1.73 m2
- •Mild renal dysfunction defined as serum creatinine > 124µmol/L (1.4 mg/dl) or eGFR <60 ml/min/1.73 m2 and proteinuria or blood pressure >130/80 mmHg
- •Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
- •Concurrent treatment with a statin or a fibrate (subjects on cholesterol-lowering diets or drugs other than statins or fibrates can still be included).
- •Concurrent treatment with an angiotensin receptor blocker, ACE inhibitor, a thiazide diuretic or a statin.
- •Other serious medical illness likely to interfere with study participation or with the ability to complete the trial
- •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
- •Concurrent use of an experimental pharmacological agent
- •*Subjects with persistently elevated blood pressure and who are considered by the local physician to require antihypertensive therapy can be entered in the trial after blood pressure control is attained with lifestyle interventions or with drugs other than an ARB, an ACE inhibitor or a thiazide diuretic. Subjects on lipid lowering therapy other than a statin or a fibrate can be entered in the trial.
研究者
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