Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial

Not Applicable

Completed

• Conditions: Cardiovascular disease/stroke; Circulatory System; Complications and ill-defined descriptions of heart disease

• Registration Number: ISRCTN14780645
• Lead Sponsor: Hamilton Health Sciences Corporation (Canada)

Brief Summary

1. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27041480 2. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27040132 3. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27039945 4. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/26481083 5. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30814321

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-12
• Study Completion: 2013-05-31
• Last Update Posted: 8 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite of CV death, non-fatal myocardial infarction (MI) and non-fatal stroke, measured at 6 weeks, 6 months and then every 6 months until study end.

Secondary Outcome Measures

Name	Time	Method
<br> 1. The composite of CV death, non-fatal MI, non-fatal stroke, resuscitated cardiac arrest, coronary revascularisation with objective evidence of ischaemia and heart failure measured at 6 weeks, 6 months, and then every 6 months until study end<br> 2. Total mortality measured at 6 weeks, 6 months, and then every 6 months until study end<br>