Ranolazine for the Prevention of Recurrent Persistent Atrial Fibrillation After Electrical Cardioversion: A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Primary Outcome - Number of Participants With Atrial Fibrillation
研究概览
简要总结
The investigators hypothesize that ranolazine would decrease the incidence of recurrence of Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion.
详细描述
Atrial fibrillation (AF) is the most common clinically significant cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality. Although a rhythm control strategy offers no survival benefit over a rate control strategy, elective electrical cardioversion is still recommended in patients without hemodynamic instability for symptomatic relief. However, recurrences are frequent after cardioversion and antiarrhythmic medications are required to maintain sinus rhythm. Nonetheless, the use of antiarrhythmic medications is problematic because of the risk of serious potential adverse effects, including drug-induced ventricular arrhythmias.
Ranolazine is a novel antianginal agent, which inhibits the late inward sodium current and produces antiischemic effects without reducing heart rate or blood pressure. Additionally, recent preclinical as well as preliminary clinical data suggest that ranolazine exhibits distinct antiarrhythmic properties. However, there is no controlled data for the use of ranolazine to prevent recurrence of AF after electrical cardioversion of persistent AF.
The investigators hypothesize that ranolazine would decrease the incidence of recurrence of AF after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion. They will be followed at 2 weeks, 1, 3 and 6 months for clinical evaluation and electrocardiography for the detection of recurrence of AF.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with persistent atrial fibrillation, aged 21 or older
- •Duration of atrial fibrillation less than one year
- •The patient does not have any contraindications for anticoagulation
- •The patient is willing to participate in the study for a total of 6 months with 3 outpatient office visits
- •The patient has provided written informed consent during the screening visit to any test or procedure being performed, or medication being changed, for this study.
- •The patient has no clinically significant abnormal clinical laboratory values, which in the investigator's opinion precludes the patient from safely participating in the study.
排除标准
- •Any contraindication for anticoagulation
- •New York Heart Association class IV heart failure
- •Currently taking anti-arrhythmic drugs
- •Chronic kidney disease (serum creatinine less than 2.5mg/dL) or severe liver dysfunction
- •Pregnancy/nursing
- •Prolonged QT interval (>500ms)
- •Taking other medications known to prolong the QT interval
- •Taking other medications known to affect the metabolism of ranolazine
研究组 & 干预措施
Ranolazine
Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.
干预措施: Ranolazine (Drug)
Placebo
Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.
干预措施: Matching placebo (Drug)
结局指标
主要结局
Primary Outcome - Number of Participants With Atrial Fibrillation
时间窗: 6 months
To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.
次要结局
未报告次要终点