Heart Outcomes Prevention Evaluation (HOPE) - 3. How does combined cholesterol management and blood pressure lowering medicine effect risk of heart illness in middle aged people at average risk.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12705

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

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

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