FATTY ACID ANTIARRYTHMIA TRIAL (FAAT)

脂肪酸抗心律失常试验 (FAAT)

• 批准号: 6165085
• 负责人: ALEXANDER LEAF
• 金额: $ 60.53万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-03-15 至 2003-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6165085
• 关键词: antiarrhythmic agent; arrhythmia; cardiovascular disorder prevention; clinical research; clinical trials; diet therapy; dietary control; dietary lipid; dietary supplements; disease /disorder proneness /risk; electrocardiography; human subject; human therapy evaluation; implantable defibrillators; marine animal oil; nutrition related tag; placebos; sudden cardiac death; ventricular fibrillation

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.

我们的目标是确定饮食中主要来自海洋鱼油的n-3类多不饱和脂肪酸（PUFA）是否会预防人类致命的室性心动过速（VT）和心室颤动（VF）。 由于仅在美国每年就有大约250，000人死于心脏病发作后一小时内的心脏性猝死，几乎所有的心脏性猝死都是由于VT或VF，因此这是一个主要的公共卫生问题，目前还没有具体的、安全的或有效的预防或治疗方法。 它通常是严重心脏病的第一个迹象。 提示性的临床和我们确定的实验证据的n-3多不饱和脂肪酸的抗肿瘤作用迫切支持一个严格的临床试验。 目的：确定定期摄入n-3 PUFA是否会显著降低心脏性猝死的风险。我们建议在植入心脏起搏器（ICD）的患者中进行一项前瞻性、安慰剂对照、双盲临床试验，以测试与橄榄油补充剂相比，定期摄入鱼油补充剂是否会在一年内显著减少ICD的治疗性放电次数，我们发现橄榄油补充剂没有抗心律失常作用。 这将是一项二级预防试验，在400例因心脏骤停而植入ICD的患者中进行，这些患者幸运地从心脏骤停中复苏，无需改变常规护理或患者风险。 我们只需要从ICD记录治疗放电的次数，并从记录的心电图条确认诱导ICD反应的心律失常类型。这似乎是最简单，最安全，最快，最便宜，非侵入性，明确的临床试验来验证我们的假设。 这是一项真正的死亡率终点试验，因为如果受试者不受ICD保护，则每次ICD出院都将导致死亡。 在过去的三年里，我们一直在制定这项研究的方案，同时在实验室中建立了这些n-3 PUFA是有效的抗肿瘤药物的证据。