Heart Outcomes Prevention Evaluation (HOPE-3)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 11000

Inclusion Criteria

•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

Exclusion Criteria

•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Heart Outcomes Prevention Trial (HOPE)-3 - HOPE-3

Population Health Research Institute (PHRI), McMaster University/Hamilton Health Sciences

Updated 6/26/2012