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临床试验/NCT00259025
NCT00259025已完成2 期

The Effect of Intravenous n-3 Polyunsaturated Fatty Acids on Risk Markers for Sudden Cardiac Death in Hemodialysis Patients

Aalborg University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年9月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
2
主要终点
Heart rate variability

研究概览

简要总结

The main purpose of this study is to investigate whether intravenous infusion of a lipid emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis patients.

详细描述

Cardiovascular disease is the most common cause of death in haemodialysis (HD)patients, and half of these deaths are due to sudden cardiac death caused by ventricular arrhythmias. HD patients have an attenuated heart rate variability (HRV) and a high frequency of ventricular arrhythmias, both of which are predictors of sudden cardiac death(SCD). n-3 polyunsaturated fatty acids (PUFA) improves HRV and reduces the risk of SCD. n-3 PUFAs are obtained from fatty fish and fish oil and are incorporated into cell membranes after long-term ingestion. However, it is not known if this incorporation is essential or merely serves as storage for n-3 free PUFAs to be release during for instance myocardial ischaemia.

The study hypothesis is that intravenous infusion of a lipid emulsion with a high content of n-3 PUFAs will improve HRV and ventricular repolarization and reduce ventricular arrhythmias via an acute increase in free non-esterified n-3 PUFAs in plasma.

In a randomized, placebo-controlled design a n-3 PUFA rich emulsion (or placebo) will be administered during hemodialysis treatment. The two study groups will be compared with respect to heart rate variability, ventricular repolarization parameters, ventricular ectopic beats and arrhythmias and the content of n-3 PUFA in plasma and cell membranes will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 yrs
  • End-stage renal failure
  • Maintenance haemodialysis treatment > 3 months

排除标准

  • Allergy to fish or egg protein
  • Body weight < 50 kgs
  • Chronic supraventricular tachycardia
  • Implanted pacemaker
  • Myocardial infarction within 6 months
  • PCI or CABG within 6 months
  • Stroke or TIA within 6 months
  • HbA1C > 10 %
  • ALAT > 100 U/l
  • Triglycerides > 3 mmol/l
  • Ongoing infection
  • Tendency to severe blood pressure drops during dialysis treatment
  • Malignancy
  • Psychiatric disorder
  • Pregnancy

结局指标

主要结局

Heart rate variability

次要结局

  • Ventricular repolarization, ventricular arrhythmias
  • n-3 polyunsaturated fatty acids in plasma and cell membranes

研究者

申办方类型
Other

研究点 (2)

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