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

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ClinicalTrials.gov Identifier: NCT00161369
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 21, 2005
Sponsor:
Collaborators:
Maruyama Memorial General Hospital
Hamamatsu University
Information provided by:
University of Shizuoka

Brief 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.

Condition or disease
Chronic Renal Failure Hemodialysis Atherosclerosis

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.

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Study Type : Observational
Enrollment : 200 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Contribution of Homocysteine and Asymmetric Dimethylarginine to Atherosclerosis and Cardiovascular Events in Maintenance Hemodialysis Patients
Study Start Date : April 2000
Study Completion Date : March 2005

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161369


Locations
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Japan
University of Shizuoka
Shizuoka, Japan, 422-8526
Sponsors and Collaborators
University of Shizuoka
Maruyama Memorial General Hospital
Hamamatsu University
Investigators
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Study Chair: Hiromichi Kumagai, MD University of Shizuoka
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ClinicalTrials.gov Identifier: NCT00161369    
Other Study ID Numbers: CT2005001
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 21, 2005
Last Verified: October 2005
Keywords provided by University of Shizuoka:
homocysteine
asymmetric dimethylarginine
atherosclerosis
cardiovascular event
hemodialysis
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic