Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)
Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)
Study Objective:

 1. To evaluate whether combined therapy with folic acid 2.5 mg/day, vitamin B6 50 mg/day and
 vitamin B12 1000 micrograms/day vs placebo reduces the rate of atherosclerosis progression,
 as evaluated by quantitative B-mode carotid ultrasound (US).
The HART study is designed as a substudy of the Heart Outcomes Prevention Evaluation-2
 (HOPE-2)trial which evaluates the effect of combined therapy ? folic acid and vitamin B6 and
 B12 on clinical events. The study is designed to enrol 900 study participants randomized to
 homocysteine lowering therapies or placebo. Follow-up will estimate over 5 years. Study
 participants will undergo yearly carotid B-Mode ultrasound examinations.
Inclusion Criteria:Women and Men aged ≥ 55 years at high risk for CV events with: (a)
 Documented (CAD): i) History of prior MI; ii) stable or unstable angina with documented
 multivessel CAD or strongly positive stress test; iii) Multivessel CAD and PTCA ≥ 6 months
 prior to randomization; iv) multivessel CABG ≥ 4 years prior to randomization; v)
 Multivessel CAD on angiography; (b) Documented peripheral vascular disease (PVD): i)
 Previous limp bypass surgery and/or previous peripheral percutaneous transluminal
 angioplasty and/or previous limp or foot amputation due to PVD.ii) History of intermittent
 claudication with ankle/arm blood pressure ratio of ≤ 0.80 or with significant arterial
 stenosis on angiography; (c) Documented cerebrovascular disease: i) History of previous
 ischemic stroke; and (d) Diabetes mellitus with ≥ 1 additional major CV risk factor(s). (2)
 Provision of informed consent.(3) Adequate baseline carotid US examination.

 Exclusion Criteria:1. Current use of folic acid supplements > 200 mg/day. 2. Known previous
 adverse reactions to folic acid, Vitamin B6 or B12. 3. Planned cardiac, peripheral or
 cerebrovascular.

 -