NCT00189319已完成4 期
Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).
研究概览
简要总结
The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In sinus rhythm at treatment initiation
- •Experienced symptomatic AF episodes
- •Left ventricular ejection fraction of at least 40%
- •Females of child bearing potential must be using reliable method of contraception
排除标准
- •Intolerance and/or failure of previous therapy with flecainide immediate release
- •Currently receiving >200mg/day flecainide immediate release
- •Severe symptoms during episodes of arrhythmia
- •History of other cardiac conditions/abnormalities
- •Heart surgery within the last 2 months
- •Renal failure
- •Pregnant or lactating females
- •Significant extra cardiac or systemic disease
- •Abnormal electrolyte levels
- •Receiving defined cardiac and/or other treatments
结局指标
主要结局
To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).
次要结局
- assessment of treatment success based on an efficacy/safety composite criterion;
- assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination;
- assessment of the relationship between QoL changes and outcomes related to safety and efficacy;
- assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography;
- evaluation of the course of the disease by the time to the first recurrence of a PAF episode and the subjective symptomatology (duration and severity of PAF episodes).
研究者
研究点 (2)
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