Condition category
Circulatory System
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
13/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mcmaster.ca/

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

Publication citations

Additional files

Editorial Notes