Rationale and design of a study assessing treatment strategies of atrial fibrillation in patients with heart failure: The Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial

被引:97
作者
Agner, E [1 ]
Sygehus, H [1 ]
Aguinaga, L [1 ]
Andersen, HB [1 ]
Arnold, JMO [1 ]
Atie, J [1 ]
Bagger, H [1 ]
Battler, E [1 ]
Bellorini, M [1 ]
Berning, J [1 ]
Bernstein, V [1 ]
Bishop, W [1 ]
Boccardo, DA [1 ]
Bonet, J [1 ]
Borggrefe, M [1 ]
Borts, D [1 ]
Bose, S [1 ]
Buxton, A [1 ]
Caeiro, AA [1 ]
Capone, RJ [1 ]
Carlos, J [1 ]
Jorge, M [1 ]
Caspi, A [1 ]
Chandrashekar, Y [1 ]
Connors, S [1 ]
Constance, C [1 ]
Corrado, G [1 ]
Costi, P [1 ]
Coutu, B [1 ]
Davies, T [1 ]
de Paola, AAV [1 ]
Delage, F [1 ]
Demers, C [1 ]
De Roy, L [1 ]
Dion, D [1 ]
Dionne, N [1 ]
Dong, R [1 ]
Dorian, P [1 ]
Dubner, S [1 ]
Egstrup, K [1 ]
Eldar, M [1 ]
Forzami, T [1 ]
Fruergaard, P [1 ]
Gadsboll, N [1 ]
Garand, M [1 ]
Garcia-Palmieri, MR [1 ]
Gardner, MG [1 ]
Gebhardt, V [1 ]
Giannetti, N [1 ]
Giannoccaro, J [1 ]
机构
[1] Montreal Heart Inst, Montreal, PQ H1T 1C8, Canada
基金
加拿大健康研究院;
关键词
D O I
10.1067/mhj.2002.125326
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Nonrandomized studies suggest that atrial fibrillation is independently associated with increased mortality in patients with heart failure. Whether restoring and maintaining sinus rhythm will have a beneficial impact on cardiovascular mortality in patients with heart failure has never been tested in an adequately powered randomized trial. Objective The primary objective of the Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is to determine whether, restoring and maintaining sinus rhythm significantly reduces cardiovascular mortality compared with a rate-control strategy in patients with atrial fibrillation and CHF. Methods AF-CHF is a prospective multicenter trial (109 centers in Canada, United States, South America, Europe, and Israel), that will randomize 1450 patients with CHIF with left ventricular ejection fraction less than or equal to 35% and atrial fibrillation to 1 of 2 treatment strategies: (1) rhythm control with the use of electrical cardioversion combined with antiarrhythmic drugs (amiodarone or other class III agents), (2) rate control with the use of beta-blockers, digoxin, or pacemaker and AV nodal ablation. Cardiovascular mortality is the primary end point and the intention-to-treat approach the primary method of analysis. We anticipate an 18.75% 2-year. cardiovascular mortality in the rate control arm with a 25% mortality reduction in the rhythm control group. Results As of August 13, 2002, 334 patients have been enrolled from 68 participating centers. Enrollment is expected to be concluded in May 2003 with a minimum follow-up of 2 years. Conclusion The results of this trial should provide definitive information concerning 2 widely applicable treatment strategies of atrial fibrillation in a large cohort of patients with CHF.
引用
收藏
页码:597 / 607
页数:11
相关论文
共 87 条
[1]   Electrophysiologic mechanisms of perpetuation of atrial fibrillation [J].
Allessie, MA ;
Konings, K ;
Kirchhof, CJHJ ;
Wijffels, M .
AMERICAN JOURNAL OF CARDIOLOGY, 1996, 77 (03) :A10-A23
[2]   NATURAL-HISTORY AND PATTERNS OF CURRENT PRACTICE IN HEART-FAILURE [J].
BOURASSA, MG ;
GURNE, O ;
BANGDIWALA, SI ;
GHALI, JK ;
YOUNG, JB ;
ROUSSEAU, M ;
JOHNSTONE, DE ;
YUSUF, S .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 1993, 22 (04) :A14-A19
[3]   Shattuck lecture - Cardiovascular medicine at the turn of the millennium: Triumphs, concerns, and opportunities [J].
Braunwald, E .
NEW ENGLAND JOURNAL OF MEDICINE, 1997, 337 (19) :1360-1369
[4]   Assessment of atrioventricular junction ablation and VVIR pacemaker versus pharmacological treatment in patients with heart failure and chronic atrial fibrillation - A randomized, controlled study [J].
Brignole, M ;
Menozzi, C ;
Gianfranchi, L ;
Musso, G ;
Mureddu, R ;
Bottoni, N ;
Lolli, G .
CIRCULATION, 1998, 98 (10) :953-960
[5]   Assessment of atrioventricular junction ablation and DDDR mode-switching pacemaker versus pharmacological treatment in patients with severely symptomatic paroxysmal atrial fibrillation - A randomized controlled study [J].
Brignole, M ;
Gianfranchi, L ;
Menozzi, C ;
Alboni, P ;
Musso, G ;
Bongiorni, MG ;
Gasparini, M ;
Raviele, A ;
Lolli, G ;
Paparella, N ;
Acquarone, S .
CIRCULATION, 1997, 96 (08) :2617-2624
[6]  
Calkins H, 1999, AM J CARDIOL, V83, p227D
[7]  
Camm AJ, 2000, J AM COLL CARDIOL, V35, p153A
[8]  
CARSON PE, 1993, CIRCULATION, V87, P102
[9]   Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. [J].
Cazeau, S ;
Leclercq, C ;
Lavergne, T ;
Walker, S ;
Varma, C ;
Linde, C ;
Garrigue, S ;
Kappenberger, L ;
Haywood, GA ;
Santini, M ;
Bailleul, C ;
Daubert, JC .
NEW ENGLAND JOURNAL OF MEDICINE, 2001, 344 (12) :873-880
[10]   Hemodynamic effects of an irregular sequence of ventricular cycle lengths during atrial fibrillation [J].
Clark, DM ;
Plumb, VJ ;
Epstein, AE ;
Kay, GN .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 1997, 30 (04) :1039-1045