Clinical trial NCT00161369: Effect of Homocysteine and Asymmetric Dimethylarginine on Cardiovascular Events in Hemodialysis Patients
Official title: Contribution of Homocysteine and Asymmetric Dimethylarginine to Atherosclerosis and Cardiovascular Events in Maintenance Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Failure
Hemodialysis
Atherosclerosis
Keywords: homocysteine
asymmetric dimethylarginine
atherosclerosis
cardiovascular event
hemodialysis
Lead sponsor: University of Shizuoka
Sponsor class: OTHER
Collaborators: name: Maruyama Memorial General Hospital
name: Hamamatsu University
First posted: 2005-09-12
Enrollment: 200
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shizuoka
country: Japan
facility: University of Shizuoka
Study officials:
affiliation: University of Shizuoka
name: Hiromichi Kumagai, MD
role: STUDY_CHAIR
References: