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Effect of Homocysteine and Asymmetric Dimethylarginine on Cardiovascular Events in Hemodialysis Patients

NCT ID: NCT00161369

Last Updated: 2005-10-21

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

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-04-30

Study Completion Date

2005-03-31

Brief Summary

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Homocysteine (Hcy) and asymmetric dimethylarginine (ADMA) have recently been recognized as potential risk factors for atherosclerosis in the general population, and the metabolism of each of these substances seems to be closely related. This study investigates the association between these substances, and whether elevated serum levels of Hcy and ADMA would be related to a high risk of atherosclerosis and cardiovascular events in maintenance hemodialysis (HD) patients.

Detailed Description

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Objective- Homocysteine (Hcy) and asymmetric dimethylarginine (ADMA) have recently been recognized as potential risk factors for atherosclerosis in the general population, and the metabolism of each of these substances seems to be closely related. This study investigates the association between these substances, and whether elevated serum levels of Hcy and ADMA would be related to a high risk of atherosclerosis and cardiovascular events in maintenance hemodialysis (HD) patients.

Methods- The subjects were recruited from both day-time and night-time HD patients at Maruyama Hospital. The study inclusion criteria were those patients who had been receiving hemodialysis therapy for more than 6 months, were in a stable condition and were under 70 years old. The degree of atherosclerosis was evaluated by four indices involving the carotid artery intima-media thickness (IMT), carotid artery plaque, percentile of calcification index in the abdominal aortic wall (ACI) and elongation of the thoracic aorta. At the same time, plasma Hcy and ADMA were measured. After the initial laboratory examination and evaluation of the degree of atherosclerosis, all the patients were followed up for 5 years.

Conditions

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Chronic Renal Failure Hemodialysis Atherosclerosis

Keywords

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homocysteine asymmetric dimethylarginine atherosclerosis cardiovascular event hemodialysis

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Exclusion Criteria

* Any patients showing signs of heart failure or a history of such apparent cardiovascular diseases as myocardial infarction, cardiac valve diseases and stroke were excluded.
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maruyama Memorial General Hospital

OTHER

Sponsor Role collaborator

Hamamatsu University

OTHER

Sponsor Role collaborator

University of Shizuoka

OTHER

Sponsor Role lead

Principal Investigators

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Hiromichi Kumagai, MD

Role: STUDY_CHAIR

University of Shizuoka

Locations

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University of Shizuoka

Shizuoka, Shizuoka, Japan

Site Status

Countries

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Japan

Other Identifiers

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CT2005001

Identifier Type: -

Identifier Source: org_study_id