Heart Outcomes Prevention Evaluation-2 (HOPE-2) study

Completed

• Conditions: Cardiovascular disease, myocardial infarction (MI), stroke, cancer; Circulatory System; Other and unspecified disorders of the circulatory system

• Registration Number: ISRCTN14017017
• Lead Sponsor: McMaster University (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5552

Inclusion Criteria

1. Women and men 55 years of age or over with established CVD and at high risk for future fatal and nonfatal CV events defined as:
1.1. Documented coronary artery disease (CAD)
1.2. Documented peripheral vascular disease (PVD)
1.3. Documented cerebrovascular disease
1.4. Diabetes with one of the following additional cardiovascular risk factors:
1.4.1. Hypertension (blood pressure [BP] greater than 160 mmHg systolic or greater than 90 mmHg diastolic or on treatment)
1.4.2. Total cholesterol greater than 5.2 mmol/l (greater than 200 mg/dl)
1.4.3. High density lipoprotein (HDL) cholesterol less than 0.9 mmol/l (3.5 mg/dl)
1.4.4. Current cigarette smoker
1.4.5. Any evidence of previous vascular disease
2. Provision of informed consent

Exclusion Criteria

1. Current use of any vitamin supplements containing folic acid greater than 200 µg/day. Patients taking such vitamin supplements can be asked if they agree to discontinue these supplements. If they agree they can be randomised to the study.
2. Known previous adverse reactions to folic acid, vitamin B6 or B12
3. Planned cardiac, peripheral or cerebrovascular revascularization, defined as a decision taken by the patient and his or her physician(s) to perform surgical or percutaneous transluminal revascularisation within the next 6 months
4. Haemodynamically significant primary valvular outflow tract obstruction (e.g. mitral stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve)
5. Constrictive pericarditis
6. Complex congenital heart disease
7. Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias (asymptomatic arrhythmias including ventricular tachycardia are not exclusion criteria)
8. Uncontrolled hypertension
9. Cor pulmonale
10. Heart transplant recipient
11. Other important non-cardiovascular disease(s) expected to limit compliance and/or impact on patient?s ability to complete the study, such as: history of alcohol or drug abuse, psychiatric disorders, senility, severe physical disability, illnesses including terminal stage cancer and other major systemic illnesses expected to limit the patient?s ability to comply with the study protocol and to complete the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified