Contact information
Type
Scientific
Primary contact
Dr Eva Lonn
ORCID ID
Contact details
HGH-McMaster Clinic
237 Barton Street East
Room 254
Hamilton
L8L 2X2
Canada
+1 905 526 0970
lonnem@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00217178
Protocol/serial number
MCT-44159
Study information
Scientific title
Acronym
HART
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).
Ethics approval
Research Ethics Board of McMaster University approved on the 2nd February 2000
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Atherosclerotic cardiovascular disease (CVD)
Intervention
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
Intervention type
Supplement
Phase
Not Applicable
Drug names
Vitamins
Primary outcome measures
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 measures
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
Overall trial start date
01/04/2000
Overall trial end date
31/10/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
921
Participant 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
Recruitment start date
01/04/2000
Recruitment end date
31/10/2005
Locations
Countries of recruitment
Canada
Trial participating centre
HGH-McMaster Clinic
Hamilton
L8L 2X2
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
Office of the Associate Dean Research
Faculty of Health Sciences
1200 Main St. W.
Room HSC-3N8
Hamilton
L8N 3Z5
Canada
+1 905 525 9140 ext. 22465
hsresadm@mcmaster.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44159)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary