Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery (FLIP-AF): a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Recruitment rate
研究概览
简要总结
Investigator-initiated pilot study of single dose oral flecainide versus no flecainide for the early conversion of perioperative atrial fibrillation to sinus rhythm after noncardiac surgery.
详细描述
FLIP-AF is a prospective, randomized, open-label trial of single dose flecainide versus no flecainide in patients with perioperative atrial fibrillation after noncardiac surgery. The primary objective is to determine whether it is feasible to conduct a large randomized controlled trial assessing the efficacy and safety of single dose flecainide in this population.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Noncardiac surgery in the last 30 days requiring an overnight hospital admission;
- •Presence of AF (i.e., atrial fibrillation and/or flutter) with a ventricular heart rate of ≥ 100 beats per minute at any time within 12 hours prior to randomization;
- •In AF at the time of randomization; AND,
- •Provided written informed consent.
排除标准
- •History of AF without normal sinus rhythm documented within 90 days prior to randomization;
- •Hemodynamic instability;
- •Have any one of the following contraindications to flecainide:
- •known left ventricular ejection fraction ≤ 40%;
- •myocardial infarction within the last 30 days;
- •QRS interval >140ms;
- •allergy to flecainide;
- •severe uncorrected hypokalemia (<2.5 mEq/L) or hyperkalemia (>6.5 mEq/L) at the time of randomization;
- •severe acute liver dysfunction or history of advanced cirrhosis;
- •severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR,
- •second or third degree atrioventricular block within the last 30 days, in the absence of a pacemaker device;
- •Unable to take oral medication;
- •Previously enrolled in the trial.
研究组 & 干预措施
Flecainide
Participants randomized to the flecainide arm will be prescribed a single 300mg dose of oral flecainide, to be given as soon as possible after study randomization. Rate controlling drugs will be prescribed and titrated to achieve a heart rate of less than 100 beats per minute and symptom minimization.
干预措施: Flecainide (Drug)
结局指标
主要结局
Recruitment rate
时间窗: through study completion, an average of six months
Minimum recruitment rate of at least 1.5 patients per site per month
Follow-up completion rate
时间窗: through study completion, an average of six months
Completion rate of at least 90%
次要结局
未报告次要终点