Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker
Intravenous Infusion of n-3 Polyunsaturated Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)
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.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Aalborg、丹麦、9000
- Department of Cardiology, Aalborg Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:一个
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Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h)
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安慰剂比较:乙
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Intravenous infusion, 100 mL, 25mL/h
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Inducibility of ventricular tachycardia
大体时间:Hours
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Hours
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次要结果测量
结果测量 |
大体时间 |
---|---|
Heart rate variability
大体时间:Hours
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Hours
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Ventricular repolarization parameters
大体时间:Hours
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Hours
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Concentration of n-3 fatty acids in plasma and platelet membranes
大体时间:Hours
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Hours
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合作者和调查者
调查人员
- 首席研究员:Trine Madsen, MD、Aalborg Hospital, Aarhus University Hospital, Denmark
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Omegaven的临床试验
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Fresenius Kabi撤销营养不良 | 小儿ALL | 神经认知缺陷 | 肠外营养相关性肝病 | 必需脂肪酸缺乏症
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General University Hospital, PragueCharles University, Czech Republic; Ministry of Health, Czech Republic完全的
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Fresenius Kabi尚未招聘营养不良 | 小儿ALL | 必需脂肪酸缺乏症 | 肠外营养相关性肝病 (PNALD)