Disertori Marcello, Latini Roberto, Maggioni Aldo Pietro, Delise Pietro, Di Pasquale Giuseppe, Franzosi Maria Grazia, Staszewsky Lidia, Tognoni Gianni
Department of Cardiology, S. Chiara Hospital, Trento, Italy.
J Cardiovasc Med (Hagerstown). 2006 Jan;7(1):29-38. doi: 10.2459/01.JCM.0000199778.85343.08.
The possibility of preventing atrial fibrillation recurrence with anti-arrhythmic agents is very limited, given the discouraging results obtained with current drugs in many patients. Data from experimental studies suggest that angiotensin II AT1-receptor blockers can influence atrial remodelling, a key factor in atrial fibrillation initiation and maintenance. Moreover, some preliminary clinical data show that angiotensin II AT1 -receptor blockers can prevent atrial fibrillation episodes. The GISSI-Atrial Fibrillation (AF) trial is a randomized, prospective, parallel group, placebo-controlled, multicentre study designed to test whether angiotensin II AT1-receptor blockers can reduce atrial fibrillation recurrence.
The primary objective of the study is to demonstrate that, in patients with a history of recent atrial fibrillation who are treated with the best recommended therapies, the addition of the angiotensin II AT1-receptor blocker valsartan (titrated up to 320 mg) is superior to placebo in reducing atrial fibrillation recurrence. A substudy will analyse the effect of valsartan on left atrial dimensions and on neurohormones. The study population consists of patients with symptomatic atrial fibrillation (at least two electrocardiogram documented atrial fibrillation episodes in the previous 6 months or successful cardioversion in the last 2 weeks) with underlying cardiovascular diseases or comorbidities. With approximately 100 centres participating in Italy, a total of 1402 patients are randomized in a 1 : 1 ratio to receive valsartan or placebo. The enrolment period will last 12 months and the patients will be followed for 12 months from study entry.
The GISSI-AF is the largest trial aimed at assessing the role of angiotensin receptor blockade in reducing the recurrence of atrial fibrillation and its possible mechanisms of action in terms of its effects on atrium remodelling and neurohormones.
鉴于目前的药物在许多患者中取得的令人沮丧的结果，使用抗心律失常药物预防房颤复发的可能性非常有限。实验研究数据表明，血管紧张素II AT1受体阻滞剂可影响心房重构，这是房颤发生和维持的关键因素。此外，一些初步临床数据显示，血管紧张素II AT1受体阻滞剂可预防房颤发作。GISSI-房颤（AF）试验是一项随机、前瞻性、平行组、安慰剂对照、多中心研究，旨在测试血管紧张素II AT1受体阻滞剂是否能降低房颤复发率。
该研究的主要目的是证明，在接受最佳推荐治疗的近期有房颤病史的患者中，加用血管紧张素II AT1受体阻滞剂缬沙坦（滴定至320毫克）在降低房颤复发率方面优于安慰剂。一项子研究将分析缬沙坦对左心房大小和神经激素的影响。研究人群包括有症状性房颤（过去6个月内至少有两次心电图记录的房颤发作或过去2周内成功复律）且伴有潜在心血管疾病或合并症的患者。意大利约有100个中心参与，共1402例患者按1:1比例随机接受缬沙坦或安慰剂治疗。入组期将持续12个月，患者将从研究入组开始随访12个月。
GISSI-AF是旨在评估血管紧张素受体阻滞剂在降低房颤复发率方面的作用及其对心房重构和神经激素影响的可能作用机制的最大规模试验。
