Carvedilol for Prevention of Paroxysmal Atrial Fibrillation
关键词
抽象
描述
The study population will consist of patients with electrocardiographically documented symptomatic paroxysmal AF (≥ 2 episodes of ≥ 15 min duration within a six month period) while on stable antiarrhythmic drug therapy. Patients will be excluded if they have AF due to a reversible cause, persistent AF, significant heart failure or a life expectancy of less than one year. Eligible patients will be randomized to carvedilol or metoprolol and followed for 13 months. Randomization will be stratified based on the AF management strategy (rate or rhythm control). Carvedilol and metoprolol will be initiated over a one month drug titration period to achieve doses of 25mg bid and 50 mg bid respectively. AF occurrence will be documented using event recorders. The co-primary outcome measures are survival free from AF after one month blanking period for drug titration and the number of days in AF detected during follow-up. Secondary outcomes include event free survival to first symptomatic episode of AF, days in symptomatic AF, time between first and second episodes of AF, proportion of patients who develop persistent AF, AF Severity Scale, CCS-AF symptom score, ventricular rate during AF, proportion of patients with discontinuation of the assigned therapy and number of emergency department visits or hospitalizations for cardiovascular causes. Adverse effects and need to discontinue carvedilol or metoprolol will be documented. This study will determine whether carvedilol is safe and effective for prevention of recurrent paroxysmal AF in a general population with AF. Data will be analyzed on an intention to treat basis. Three hundred patients will be recruited over 4 years. The sample size is based on an estimated 20% reduction in event free survival from AF (power 0.90, α = 0.05). Patients will be recruited from our AF clinic population which averages 50 new referrals per month and over 2500 referrals since it's' inception in 2005.
日期
最后验证: | 03/31/2019 |
首次提交: | 05/27/2012 |
提交的预估入学人数: | 05/29/2012 |
首次发布: | 05/30/2012 |
上次提交的更新: | 04/14/2019 |
最近更新发布: | 04/15/2019 |
实际学习开始日期: | 04/30/2012 |
预计主要完成日期: | 05/31/2020 |
预计完成日期: | 05/31/2020 |
状况或疾病
干预/治疗
Drug: Carvedilol
Drug: Metoprolol
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Metoprolol The metoprolol arm patients are stratified by the arrhythmia management strategy Rate or Rhythm control and metoprolol is dose titrated from 25 mg bid to a maximum of 50 mg bid over one month then patients are followed for 6 months. | Drug: Metoprolol titrated to 50 mg po bid as tolerated over a 1 month period |
Active Comparator: Carvedilol The carvedilol arm patients are stratified by the arrhythmia management strategy Rate or Rhythm control and carvedilol is dose titrated from 3.25 mg bid to maximum dose of 25 mg bid over one month then patients are followed for 6 months. | Drug: Carvedilol 6.25 po bid titrated to 25 mg bid as tolerated over a 1 month period |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Must be in sinus rhythm at enrollment - ECG documented symptomatic PAF (> 2 episodes of > 15minutes duration over a 6 month period) Exclusion Criteria: - AF due to reversible causes - Contraindication or previous significant adverse reaction to Beta blocker therapy - Persistent AF - NYHA Class II or greater CHF - LVEF < or = 35% - Life expectancy < 1 year - Geographic isolation - Unable to give informed consent |
结果
主要结果指标
1. Event-free survival to first detected AF after the one month blanking period for dose titration [1 year]
次要成果指标
1. number of Emergency room visits/hospitalizations for cardiovascular causes [1 year]
2. Proportion of patients who develop persistent AF [1 year]
3. Days in symptomatic AF/Time between successive PAF episodes [1 year]
4. AF Severity Scale [1 year]
5. Adverse effects of assigned therapy [1 year]
6. Ventricular rate during AF [1 year]
7. CCS AF Symptom Score [1 yr]