Pharmacologic Suppression of Central Sympathetic Activity for Prevention of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation (MOXAF)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- AFib recurrence
研究概览
简要总结
Hypothesis: Modulation of central nervous sympathetic activation by administration of moxonidine, a centrally acting medication which decreases the sympathetic nervous system activity, can lead to a decrease in atrial fibrillation recurrence after ablation treatment with pulmonary vein isolation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive patients with paroxysmal atrial fibrillation.
- •At least two documented episodes within the last 12 months (either self-terminating within 7 days or cardioverted, medically or electrically, in less than 48 hours).
- •At least one episode should have been documented under treatment with a class Ic or III antiarrhythmic drug.
排除标准
- •age <25 or >80 years
- •presence of atrial thrombus
- •left atrial volume index >55 ml/m2
- •hypersensitivity to moxonidine
- •sick sinus syndrome or sino-atrial block
- •2nd or 3rd degree atrioventricular block
- •bradycardia (below 50 beats/minute at rest)
- •estimated glomerular filtration rate <40 ml/min/1.73 m2
- •history of angioneurotic oedema
- •heart failure symptoms OR impaired left ventricular function (EF <40%), even if asymptomatic
- •stable or unstable angina pectoris
- •intermittent claudication or known peripheral artery disease
- •Parkinson's disease
- •epileptic disorders
- •history of depression
- •pregnancy or lactation
- •inability or unwillingness to adhere to standard treatment or to provide consent.
研究组 & 干预措施
Control group
The patients of the control group will undergo standard ablation procedure (pulmonary vein isolation) and will receive placebo, starting one week before scheduled ablation.
Optimal antihypertensive treatment will be prescribed, with adequate follow-up to ensure good control of hypertension (goal <= 140/90).
干预措施: Placebo (Drug)
Moxonidine group
Patients of the active treatment group will receive moxonidine in a starting dose of 0.2 mg daily. The first dose will be administered 1 week before scheduled ablation. 3 weeks after the first dose the daily dose will be increased to 0.4 mg, if the lower dose is well tolerated.
Optimal antihypertensive treatment, in addition to moxonidine, will be prescribed, if needed, with adequate follow-up to ensure good control of hypertension (goal <= 140/90).
干预措施: Moxonidine (Drug)
结局指标
主要结局
AFib recurrence
时间窗: 12 months+
Any of the following, occuring after a 3-month blanking period, will be considered an AF recurrence: * symptomatic recurrence (AF/MRAT of any duration in ECGs performed in patients reporting symptoms of arrhythmia); the patients will be encouraged to visit the research site or any affiliated center to have an ECG performed at any time (24/7) they may feel symptoms of arrhythmia during the study follow-up * AF/MRAT of at least 30 seconds in duration in 48-hour Holter recordings performed monthly * AF/MRAT of any duration recorded in electrocardiograms performed during patient visits at the arrhythmia clinic, even if the patient is asymptomatic (AF=atrial fibrillation, MRAT=macro-reentrant atrial tachycardia)
次要结局
- Depressive symptoms(6 months)
- Early AFib recurrence(2 months)
研究者
Spyridon Deftereos
Director; Catheterization Laboratory and Cardiac Electrophysiology Laboratory
G.Gennimatas General Hospital