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临床试验/NCT02322697
NCT02322697已完成不适用

Effects of Chronic Intravenous Administration of L-carnitine on Myocardial Fatty Acid Metabolism in Hemodialysis Patients

Toujinkai Hospital0 个研究点目标入组 60 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
changes in BMIPP summed scores of the SPECT imaging

研究概览

简要总结

Patients on chronic hemodialysis without obstructive coronary artery disease identified by coronary angiography were randomly divided into the two groups: carnitine group and control group. SPECT using FFA analogue, BMIPP, was performed before and one year after intravenous administration of L-carnitine (1000 mg on every dialysis session). Control group received the examination of BMIPP SPECT at the same time of the carnitine group. The effects of chronic intravenous administration of L-carnitine on myocardial fatty acid metabolism were investigated among this population.

详细描述

Patients on chronic hemodialysis in Toujinkai hospital who had no obstructive coronary artery disease identified by coronary angiography and left ventricular dysfunction were randomly divided into the two groups: carnitine group and control group. To evaluate the possible effect of carnitine administration on myocardial fatty acid metabolism, SPECT using FFA analogue, BMIPP, was performed before and one year after intravenous administration of L-carnitine (1000 mg on every dialysis session). Control group received the examination of BMIPP SPECT at the same time of the carnitine group. Circulating concentrations of total, free, and acyl L-carnitine were measured every three months in the carnitine group. Clinical data including blood chemistry, blood pressure, or cardiac functions by echocardiography were obtained every 6 months in both groups. The effects of chronic intravenous administration of L-carnitine on myocardial fatty acid metabolism and cardiac functions were investigated among this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients on chronic hemodialysis without significant obstructive coronary artery disease identified by angiography within one years of the study, and who had left ventricular dysfunction:
  • reduced left ventricular systolic function (left ventricular ejection fraction <55%) and/or
  • left ventricular hypertrophy evaluated by echocardiography)

排除标准

  • Moderate or worse valvular heart disease,
  • Past histories of acute or old myocardial infarction and/or coronary revascularization by percutaneous coronary intervention or coronary artery bypass grafting within one year of the study.

研究组 & 干预措施

Carnitine group

Experimental

Intravenous administration of L-carnitine 1000mg after each hemodialysis session (three times a week) for one year.

干预措施: Intravenous administration of L-carnitine (Drug)

结局指标

主要结局

changes in BMIPP summed scores of the SPECT imaging

时间窗: one year: September 2013-October 2014 (up to 2 years)

次要结局

未报告次要终点

研究者

发起方
Toujinkai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Masato Nishimura, MD

Director of cardiovascular division

Toujinkai Hospital

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