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