Catheter Ablation Versus Medical Treatment of AF in Heart Failure (CAMTAF)
Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity and mortality associated with the other. The investigators hypothesized that restoration of normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart failure. This study randomizes patients with heart failure and persistent AF to medical treatment of AF or catheter ablation to restore sinus rhythm.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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UK
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London、UK、英国、EC1A 7BE
- Barts & The London NHS Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Persistent atrial fibrillation
- Symptomatic heart failure
Exclusion Criteria:
- Reversible causes of heart failure
- Contraindications to catheter ablation
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Catheter Ablation
Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm. |
Catheter ablation of AF as described previously by our group (e.g. Hunter et al, Heart 2010). |
|
有源比较器:Medical treatment alone
Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated). |
Medical treatment of persistent AF as 'normal care'. Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated). |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in Ejection Fraction Between Groups
大体时间:6 months
|
Difference in left ventricular ejection fraction between groups on echocardiography at 6 months |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in Peak VO2 Between Groups
大体时间:6 months
|
Looking at peak volume oxygen updake between groups |
6 months
|
|
Difference in NYHA Class Between Groups
大体时间:6 months
|
NYHA Functional Classification. classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain (Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. No NYHA class listed or unable to determine.) |
6 months
|
|
Difference in BNP Between Groups
大体时间:6 months
|
Difference in BNP between groups from 1 month onwards |
6 months
|
|
Difference in Quality of Life Between Groups
大体时间:6 months
|
Assessed from 1 month onwards. Using SF36 (total score indicating a range of low to high Quality of life) and Minnessota questionaire (Minnesota Living With Heart Failure Questionnaire (MLHFQ) uses a scale from 0 to 105, where higher scores indicate poorer health-related quality of life) |
6 months
|
|
Reduction in End Systolic Volume
大体时间:6 months compared to baseline
|
Comparisson between groups of the percentage reduction in left ventricular end systolic volume at 6 months compared to baseline. |
6 months compared to baseline
|
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Difference in Heart Failure Symptoms
大体时间:6 months
|
Comparison between groups in heart failure symptoms using The Minnesota Living with Heart Failure Questionnaire (health related quality of life- 0 to 105. Lower scores mean a better quality of life; higher scores mean worse limitations) |
6 months
|
合作者和调查者
调查人员
- 首席研究员:Richard J Schilling, MD FRCP、Professor of Cardiology, Barts & The London NHS Trust
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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