Homocysteine lowering and atherosclerosis reduction trial (HART)
| ISRCTN | ISRCTN54227421 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54227421 |
| ClinicalTrials.gov number | NCT00217178 |
| Secondary identifying numbers | MCT-44159 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 09/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Eva Lonn
Scientific
Scientific
HGH-McMaster Clinic
237 Barton Street East
Room 254
Hamilton
L8L 2X2
Canada
| Phone | +1 905 526 0970 |
|---|---|
| lonnem@mcmaster.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Correlations between plasma homocysteine and folate concentrations and carotid atherosclerosis in high-risk individuals |
| Study acronym | HART |
| Study objectives | 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(s) | Research Ethics Board of McMaster University approved on the 2nd February 2000 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2000 |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 921 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2000 |
| Date of final enrolment | 31/10/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
HGH-McMaster Clinic
Hamilton
L8L 2X2
Canada
L8L 2X2
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
Office of the Associate Dean Research
Faculty of Health Sciences
1200 Main St. W., Room HSC-3N8
Hamilton
L8N 3Z5
Canada
| Phone | +1 905 525 9140 ext. 22465 |
|---|---|
| hsresadm@mcmaster.ca | |
| Website | http://www.mcmaster.ca/ |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44159)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | baseline results | 01/11/2008 | 09/08/2019 | Yes | No |
Editorial Notes
09/08/2019: Publication reference added.
28/01/2019: Internal review.
