Intravenous Infusion of n-3 Polyunsaturated Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Inducibility of ventricular tachycardia
研究概览
简要总结
The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into cellular membranes after regular ingestion of fatty fish or fish oil.
This study investigates a possible acute effect of intravenous infusion of n-3 PUFA on inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker.
The hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase the electric stability of the myocardial cells, so that VT is more difficult to induce.
In a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously before a non-invasive electrophysiologic examination performed via the ICD and following a predefined protocol.
The main outcome is inducibility of VT. If sustained VT is induced in a patient after both n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo is compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sustained ventricular tachycardia (VT) inducible during primary electrophysiological study (before ICD implantation) and one of the following
- •Latest VT episode terminated by anti-tachycardia pacing (ATP)
- •VT induced during primary electrophysiological study terminated by ATP
排除标准
- •Premenopausal women
- •Allergy to fish or egg protein
- •Blood pressure > 160/90 (treated or untreated)
- •MI, PCI or CABG within the previous 6 months
- •HbA1c > 10%
- •ALT > 150 U/L
- •INR > 3.5
- •Plasma-potassium < 3.5 mmol/L
- •Fasting triglycerides > 3 mmol/L
- •Other serious illness
- •Inability to sign informed consent
研究组 & 干预措施
A
干预措施: Omegaven (Drug)
B
干预措施: Isotonic saline (Drug)
结局指标
主要结局
Inducibility of ventricular tachycardia
时间窗: Hours
次要结局
- Heart rate variability(Hours)
- Ventricular repolarization parameters(Hours)
- Concentration of n-3 fatty acids in plasma and platelet membranes(Hours)