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CompletedNCT00161369Updated Oct 21, 2005

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

An observational study in Chronic Renal Failure, Hemodialysis and Atherosclerosis, sponsored by University of Shizuoka. Completed at 1 site in Japan. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2005-10-21.

Sponsored by University of Shizuoka · Observational

Study type
Observational
Model
Defined population
Time perspective
Prospective
Enrollment
200
Ages
Up to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Chronic Renal Failure
  • Hemodialysis
  • Atherosclerosis

Keywords

  • homocysteine
  • asymmetric dimethylarginine
  • atherosclerosis
  • cardiovascular event
  • hemodialysis
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In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 200 is above the median of 120 across 431 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

University of Shizuoka is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

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.
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Study design

Observational model
Defined population
Time perspective
Prospective
Enrollment
200 participants
06

Study locations

1 site
  • University of Shizuoka
    Shizuoka, 422-8526, Japan
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00161369
Lead sponsor
University of Shizuoka
Collaborators
Maruyama Memorial General Hospital, Hamamatsu University
First posted
Sep 12, 2005
Start date
Apr 2000
Completion
Mar 2005
Last update
Oct 21, 2005

Study contacts

Hiromichi Kumagai, MD
study chair · University of Shizuoka
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2005. You cannot join it, but the record below documents what was studied.

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