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首页> 外文期刊>Clinical drug investigation >Angiotensin II Antagonist in Paroxysmal Atrial Fibrillation (ANTIPAF) Trial Rationale and Study Design
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Angiotensin II Antagonist in Paroxysmal Atrial Fibrillation (ANTIPAF) Trial Rationale and Study Design

机译:阵发性心房颤动的血管紧张素Ⅱ拮抗剂(ANTIPAF)试验依据和研究设计

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摘要

Background and objective: Atrial fibrillation (AF) is the most common cardiac arrhythmia. Recent experimental data and retrospective analyses of clinical trials suggest that increased levels of angiotensin II can induce an arrhythmogenic atrial substrate, which favours the occurrence of AF. The purpose of the ANTIPAF (Angiotensin II Antagonist in Paroxysmal Atrial Fibrillation) trial is to prove the principal concept that blockade of angiotensin II type 1 receptors with olmesartan medoxomil 40 mg/day suppresses paroxysmal AF episodes during a 12-month follow-up. The ANTIPAF trial is the first placebo-controlled trial analysing the occurrence of AF as the primary study endpoint. Methods: Examination of the study hypothesis in a prospective, randomised, placebo-controlled, double-blind group comparison in patients with documented paroxysmal AF (total of 422 patients) stratified by P-adrenoceptor antagonist use. The primary endpoint of the study is the percentage of days with documented episodes of paroxysmal AF identified on daily transtelephonic tele-ECG recordings. Patients will record and transmit at least one 1-minute ECG per day independent of symptoms. Furthermore, tele-ECG recordings will be transmitted in any case of symptomatic AF. The present paper summarises the rationale and design of the ANTIPAF trial.
机译:背景与目的:心房纤颤(AF)是最常见的心律不齐。最近的实验数据和临床试验的回顾性分析表明,升高的血管紧张素II水平可诱发心律失常的心房底物,从而促进房颤的发生。 ANTIPAF(阵发性心房颤动中的血管紧张素II拮抗剂)试验的目的是证明主要概念:用奥美沙坦medoxomil每天40 mg阻断1型血管紧张素II受体,可在12个月的随访期间抑制阵发性AF发作。 ANTIPAF试验是第一项安慰剂对照试验,分析了AF作为主要研究终点的情况。方法:在有前瞻性,随机,安慰剂对照,双盲组比较的研究假说中进行检查,该比较以记录的阵发性房颤患者(总共422例患者)使用P-肾上腺素受体拮抗剂分层。这项研究的主要终点是每天经脑电图远程心电图记录中发现的发作性房颤发作的天数百分比。患者每天将记录和传输至少1分钟的ECG,与症状无关。此外,在任何症状性AF情况下,都会发送远心电图记录。本文总结了ANTIPAF试验的原理和设计。

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