特发性流出道室性心律失常研究：基本原理和设计方案

Idiopathic outflow tract ventricular arrhythmias study （IOTVA Study） ：rationale and design

背景 发生在无器质性心脏病的室性心律失常又称为特发性室性心律失常（IVA）,其中大多数起源于左心室或右心室流出道.目前关于特发性流出道室性早搏（IOTPVC）与非持续性室性心动过速（NSVT）的流行病学调查、预后以及临床干预均缺乏大样本的循证医学证据.基本原理 相关研究表明,不同负荷的IOTPVC/NSVT可能对患者的影响不同.IC类抗心律失常药物和β受体阻滞剂对IVA有效,导管消融是IVA的一线治疗措施.特发性流出道室性心律失常（IOTVA）研究将评估IOTPVC/NSVT对患者心功能的影响和不同干预方案对IOTPVC/NSVT负荷≥5％的患者的安全性与有效性.设计方案 IOTVA研究包括：①调查IOTVA在医院心内科门诊和住院患者中的构成比;②随访观察未经干预的IOTVA对患者心功能及预后的影响;③探讨与安慰剂对照的抗心律失常药物治疗IOTPVC患者的安全性;④比较抗心律失常药物与导管消融治疗IOTPVC/NSVT的安全性和有效性.在上述研究的基础上,探索IOTVA的临床治疗路径.患者的随访终点包括随访研究中PVC与NSVT出现次数及心脏功能变化等.本研究的次要终点包括脑钠肽（BNP）及生活质量的改善情况等.结论 IOTVA研究将明确我国IOTVA在门诊与住院室性心律失常患者中的构成比,抗心律失常药物和导管消融治疗的安全性与有效性.

Background Idiopathic ventricular arrhythmias （IOTVA） in patients without structural heart disease mostly originate from left or right ventricular outflow tract.Data about the epidemiology,nature prognosis and treatment of idiopathic outflow tract premature ventricular complexes/nonsustained ventricular tachycardia （IOTPVC/NSVT）,which based on the large sample of clinical trial,are scarce at present.Rationale Some studies have demonstrated that effects on cardiac function of IOTPVC/NSVT are related to its burden.Antiarrhythmic drugs （class IC agents and β-blockers） and catheter ablation are effective for IOTVA.This study will assess effects on cardiac function of IOTPVC burden and compare safety and effectiveness of antiarrhythmic drugs with catheter ablation in patients with IOTPVC/NSVT.Design The IOTVA study will includes the following：①to investigate the proportion of IOTVA to ventricular arrhythmias in outpatients and inpatients at the department of cardiology; ②to inquire the prognosis and its cardiac function in IOTVA patients without any treatment; ③to assess the safety of antiarrhythmic drugs therapy compared with control therapy in IOTVA patients; ④to compare safety and effectiveness of antiarrhythmic drugs with catheter ablation in IOTPVC/NSVT patients with PVCs burden more than 15％.Based on these studies,we would establish the clinical treatment approach for IOTVA.Conclusion IOTVA study will assess effects on cardiac function of IOTPVC burden and evaluate safety and effectiveness of antiarrhythmic drugs and catheter ablation in patients with IOTPVC/NSVT.