Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)

Conditions
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Atherosclerosis, Cardiovascular Disease

Intervention / Treatment
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* Drug: Vitamins: Folic acid, B6, B12


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vitamins: Folic acid, B6, B12|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, CV Risk Factors, Homocysteine, CV disease, Cardiovascular disease