Heart Outcomes Prevention Evaluation (HOPE) - 3. A large simple randomized trial of combined cholesterol modification and blood pressure lowering in middle aged people at average risk. - Heart Outcomes Prevention Evaluation (HOPE) - 3 (version 1.8.2)

Population Health Research Institute, Hamilton Health Sciences Corporation0 个研究点目标入组 12,705 人开始时间: 2009年11月9日最近更新: 2020年7月27日

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•Women aged =60 years with at least two additional risk factors and, women aged
•>65 years and men =55 years with at least one additional risk factor
•Suggested cardiovascular risk factors for trial eligibility:
•o Waist/hip ratio =0.90 in men and =0.85 in women
•o History of current or recent smoking (regular tobacco use within 5 years)
•o Low 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)
•o Dysglycaemia (impaired fasting glucose [IFG], impaired glucose tolerance [IGT]
•or uncomplicated diabetes treated by diet only)
•o Renal dysfunction
•- microalbuminuria
•- estimated GFR <60 ml/min/1.73 m2 or creatinine >124 µmol/L (1.4 mg/dL)
•(unless the participant has proteinuria or blood pressure >130/80 mmHg)
•o Family history of premature coronary heart disease or stroke 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: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

•Documented clinically manifest atherothrombotic cardiovascular disease
•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 and/or thiazide diuretic therapy, as
•determined by the subject’s own local physician*
•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, Direct
•Renin Inhibitor or a thiazide diuretic
•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
•* 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, a Direct Renin Inhibitor or a thiazide diuretic. Subjects on lipid lowering therapy other than a statin or a fibrate can be entered in the trial.

发起方

Population Health Research Institute, Hamilton Health Sciences Corporation