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Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2004 by McMaster University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Population Health Research Institute
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00217178
First received: September 16, 2005
Last updated: NA
Last verified: October 2004
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Atherosclerosis
Cardiovascular Disease
 Drug: Vitamins: Folic acid, B6, B12
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 900
Study Start Date: January 2000
Estimated Study Completion Date: October 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217178

Locations
Canada, Ontario
Hamilton Health Sciences Corp.
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Institutes of Health Research (CIHR)
Population Health Research Institute
Investigators
Principal Investigator: Eva M Lonn, MD MSc FRCPC FACC McMaster University
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00217178     History of Changes
Other Study ID Numbers: HART, CIHR Grant # MCT 44159, CIHR, MCT 44159
Study First Received: September 16, 2005
Last Updated: September 16, 2005
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Atherosclerosis
CV Risk Factors
Homocysteine
CV disease
Cardiovascular disease

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Folic Acid
Vitamin B Complex
Vitamins
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013