Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)
This trial is active, not recruiting.
|Conditions||atherosclerosis, cardiovascular disease|
|Treatment||vitamins: folic acid, b6, b12|
|Sponsor||Hamilton Health Sciences Corporation|
|Collaborator||Canadian Institutes of Health Research (CIHR)|
|Start date||January 2000|
|End date||October 2005|
|Trial size||900 participants|
|Trial identifier||NCT00217178, CIHR, MCT 44159, HART, CIHR Grant # MCT 44159|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||factorial assignment|
The change over time (annualized progression slope) in the mean maximum IMT (the mean maximum IMT slope) defined as the average of the maximum IMT across the 12 preselected carotid arterial segments.
The change over time (annualized progression slope) in the single maximum IMT amongst any of the same preselected carotid artery segments, i.e. the hemodynamically most important lesson.
Male or female participants at least 55 years old.
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. -
|Official title||Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)|
|Principal investigator||Eva M Lonn, MD MSc FRCPC FACC|
|Description||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.|
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