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Welcome
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11 February 2012
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| [ Print-friendly version ] |
| Homocysteine lowering and atherosclerosis reduction trial (HART) |
| ISRCTN | ISRCTN54227421 |
| ClinicalTrials.gov identifier | NCT00217178 |
| Public title | Homocysteine lowering and atherosclerosis reduction trial (HART) |
| Scientific title | |
| Acronym | HART |
| Serial number at source | MCT-44159 |
| Study hypothesis | To evaluate whether combined therapy with folic acid 2.5 mg/day, vitamin B6 50 mg/day and vitamin B12 1 mg/day versus placebo reduces the rate of atherosclerosis, as evaluated by quantitative B-mode carotid ultrasound (US). |
| Lay summary | |
| Ethics approval | Research Ethics Board of McMaster University approved on the 2nd February 2000 |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Atherosclerotic cardiovascular disease (CVD) |
| Participants - inclusion criteria |
1. Women and men aged greater than or equal to 55 years at high risk for cardiovascular (CV) events with:
1.1. Documented (CAD): 1.1.1. History of prior myocardial infarction (MI) 1.1.2. Stable or unstable angina with documented multivessel coronary artery disease (CAD) or strongly positive stress test 1.1.3. Multivessel CAD and percutanerous transluminal coronary angioplasty (PTCA) greater than or equal to 6 months prior to randomisation 1.1.4. Multivessel CABG greater than or equal to 4 years prior to randomisation 1.1.5. Multivessel CAD on angiography 1.2. Documented peripheral vascular disease (PVD): 1.2.1. Previous limp bypass surgery and/or previous peripheral percutaneous transluminal angioplasty and/or previous limp or foot amputation due to PVD 1.2.2. History of intermittent claudication with ankle/arm blood pressure ratio of greater than or equal to 0.80 or with significant arterial stenosis on angiography 1.3. Documented cerebrovascular disease: history of previous ischaemic stroke 1.4. Diabetes mellitus with greater than or equal to one additional major CV risk factor(s) 2. Provision of informed consent 3. Adequate baseline carotid US examination |
| Participants - exclusion criteria |
1. Current use of folic acid supplements greater than 200 mg/day
2. Known previous adverse reactions to folic acid, vitamin B6 or B12 3. Planned cardiac, peripheral or cerebrovascular surgery |
| Anticipated start date | 01/04/2000 |
| Anticipated end date | 31/10/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 921 |
| Interventions |
Intervention:
Combination of folic acid 2.5 mg, vitamin B6 50 mg and vitamin B12 1.0 mg daily, which is expected to reduce tHcy by about one quarter to one third, even in persons who are not frankly deficient and extremely safe. Control: Placebo. Trial details received: 12 Sept 2005 |
| Primary outcome measure(s) | The change over time (annualised progression slope) in the mean maximum intima-media thickness (IMT (the mean maximum IMT slope), defined as the average of the maximum IMT across the 12 preselected carotid arterial segments. |
| Secondary outcome measure(s) |
1. The change over time (annualised progression slope) in the single maximum IMT amongst any of the same preselected carotid artery segments, i.e., the haemodynamically most important lesson
2. The effect of folate and vitamins B6, B12 therapy on clinical outcomes |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44159) |
| Trial website | |
| Publications | |
| Contact name | Dr Eva Lonn |
| Address |
HGH-McMaster Clinic
237 Barton Street East Room 254 |
| City/town | Hamilton |
| Zip/Postcode | L8L 2X2 |
| Country | Canada |
| Tel | +1 905 526 0970 |
| Fax | +1 905 527 5380 |
| lonnem@mcmaster.ca | |
| Sponsor | McMaster University (Canada) |
| Address |
Office of the Associate Dean Research
Faculty of Health Sciences 1200 Main St. W., Room HSC-3N8 |
| City/town | Hamilton |
| Zip/Postcode | L8N 3Z5 |
| Country | Canada |
| Tel | +1 905 525 9140 ext. 22465 |
| Fax | +1 905 528 8539 |
| hsresadm@mcmaster.ca | |
| Sponsor website: | http://www.mcmaster.ca/ |
| Date applied | 26/09/2005 |
| Last edited | 13/07/2009 |
| Date ISRCTN assigned | 26/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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