Homocysteine Lowering and Atherosclerosis Reduction Trial (HART)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2005-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Atherosclerosis Cardiovascular Disease

Keywords

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Atherosclerosis CV Risk Factors Homocysteine CV disease Cardiovascular disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Vitamins: Folic acid, B6, B12

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Eva M Lonn, MD MSc FRCPC FACC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Hamilton Health Sciences Corp.

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Held C, Sumner G, Sheridan P, McQueen M, Smith S, Dagenais G, Yusuf S, Lonn E. Correlations between plasma homocysteine and folate concentrations and carotid atherosclerosis in high-risk individuals: baseline data from the Homocysteine and Atherosclerosis Reduction Trial (HART). Vasc Med. 2008 Nov;13(4):245-53. doi: 10.1177/1358863X08092102.

Reference Type DERIVED

PMID: 18940900 (View on PubMed)

Other Identifiers

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CIHR, MCT 44159

Identifier Type: -

Identifier Source: secondary_id

HART, CIHR Grant # MCT 44159