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.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
UK
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London、UK、イギリス、EC1A 7BE
- Barts & The London NHS Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Persistent atrial fibrillation
- Symptomatic heart failure
Exclusion Criteria:
- Reversible causes of heart failure
- Contraindications to catheter ablation
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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). |
|
アクティブコンパレータ: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). |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in Ejection Fraction Between Groups
時間枠:6 months
|
Difference in left ventricular ejection fraction between groups on echocardiography at 6 months |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in Peak VO2 Between Groups
時間枠:6 months
|
Looking at peak volume oxygen updake between groups |
6 months
|
|
Difference in NYHA Class Between Groups
時間枠: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
時間枠:6 months
|
Difference in BNP between groups from 1 month onwards |
6 months
|
|
Difference in Quality of Life Between Groups
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
捜査官
- 主任研究者:Richard J Schilling, MD FRCP、Professor of Cardiology, Barts & The London NHS Trust
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 05/Q0605/47
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