FATTY ACID ANTIARRYTHMIA TRIAL (FAAT)

我们的目标是确定饮食中的n-3类多不饱和脂肪酸(PUFAs)是否能预防人类致命的室性心动过速(VT)和纤颤(VF)。由于每年仅在美国就有大约25万人死于心脏病发作后一小时内的心源性猝死，几乎所有的死亡都是由室性心动过速或室颤引起的，这是一个重大的公共卫生问题，目前还没有专门的、安全的或有效的预防或治疗方法。这通常是严重心脏病的第一个迹象。关于n-3多不饱和脂肪酸抗心律失常作用的提示性临床和我们确凿的实验证据迫切支持现在进行严格的临床试验。目的：确定规律摄入n-3多不饱和脂肪酸是否能显著降低心源性猝死的风险。我们建议在植入心脏除颤器(ICD)的患者中进行一项前瞻性、安慰剂对照的双盲临床试验，以测试与橄榄油补充剂相比，定期服用鱼腥草补充剂是否会在一年内显著减少ICD的治疗性放电数量，我们发现橄榄油补充剂没有抗心律失常作用。这将是对400名因先前心脏骤停而植入ICD的患者进行的二级预防试验，幸运的是，他们已从心脏骤停中复苏，不需要改变患者的常规护理或风险。我们只需要从ICD中记录治疗出院的次数，并从记录的心电图条中确认引起ICD反应的心律失常的种类。这似乎是检验我们假设的最简单、最安全、最快、最便宜、非侵入性、决定性的临床试验。这是一项真正的死亡率终点试验，因为如果受试者没有ICD的保护，每一次ICD出院都将是一次死亡。在过去的三年里，我们一直在开发这项研究的方案，同时在实验室建立了这些n-3多不饱和脂肪酸是有效的抗心律失常药物的证据。

Our goal is to determine if the dietary n-3 class of polyunsaturated fatty acids (PUFAs), provided in our diet largely from marine fish oils, will prevent fatal ventricular tachycardia (VT) and fibrillation (VF) in humans. Since there are some 250,000 deaths annually in the USA alone from sudden cardiac death within one hour of a heart attack, nearly all of which are due to VT or VF, this is a major public health problem for which at the present time there is no specific, safe, or effective preventive or therapy. It is often the first indication of serious heart disease. The suggestive clinical and our definitive experimental evidence for an antiarrhythmic effect of n-3 PUFAs urgently support a rigorous clinical trial now. Aim: To determine if regular ingestion of n-3 PUFAs will significantly reduce the risk of sudden cardiac death. We propose to conduct a prospective, placebo-controlled, double blinded, clinical trial in patients with implanted cardiac defibrillators (ICDs) to test whether the regular ingestion of a supplement of a fishoil will significantly reduce the number of therapeutic discharges of the ICDs over a period of one year, as compared with an olive oil supplement, which we have found has no antiarrhythmic action. This will be a secondary prevention trial in 400 patients who have had ICDs implanted for a prior episode of cardiac arrest, from which they were fortunately resuscitated, with no need to alter usual care or risk to the patient. We will only need to record from the ICDs the number of therapeutic discharges and confirm from the recorded electrocardiogram strips the kinds of arrhythmias which had induced the ICD response. This appears to be the simplest, safest, quickest, least expensive, non invasive, definitive clinical trial to test our hypothesis. It is a true mortality end-point trial as every ICD discharge would be a death if the subjects were not protected by the ICD. We have been developing the protocol for this study for the past three years while establishing the evidence in the laboratory that these n-3 PUFAs are potent antiarrhythmic agents.