TY - JOUR
T1 - Rationale and design of a study assessing treatment strategies of atrial fibrillation in patients with heart failure
T2 - The Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial
AU - Agner, Erik
AU - Aguinaga, Luis
AU - Andersen, Helge Bjerregård
AU - Arnold, J. Malcolm O.
AU - Reisin, Leonardo
AU - Rodriguez-Santiago, Angel
AU - Rokkedal, Jens
AU - Rozenfeld, Tiberio
AU - Rozenman, Joseph
AU - Roy, Denis
AU - Rubin, Andrew
AU - Ruel, Monique
AU - Rupka, Dennis
AU - Sacco, Joseph
AU - Samson, Michel
AU - Sandrin, Franco
AU - Schuld, Richard
AU - Senaratne, Monohara
AU - Salerno, Jorge A.
AU - Sharma, Nawal
AU - Singer, Igor
AU - Singh, Bramah N.
AU - Singh, Narendra
AU - Smiley, Nassar
AU - Sosa, Eduardo
AU - Stambler, Bruce
AU - Waldo, Albert
AU - Steinberg, Jonathan
AU - Sterns, Laurence
AU - Storm, Randle
AU - Tremblay, Gérald
AU - Tzivoni, Dan
AU - Vakani, Tarik
AU - Vered, Zvi
AU - Victor, Elizari Marcelo
AU - Vizel, Saul
AU - Vidaillet, Humberto
AU - Weigel, Michael
AU - Weiss, Ted
AU - Wulffhart, Zaev
AU - Wyse, George
AU - Zimmerman, Leandro
AU - Zuelgaray, Jorge Gonzalez
N1 - Funding Information:
Supported by an operating grant from the Canadian Institutes of Health Research, Ottawa, Ontario, Canada.
PY - 2002/10/1
Y1 - 2002/10/1
N2 - 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 CHF with left ventricular ejection fraction ≤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 β-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.
AB - 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 CHF with left ventricular ejection fraction ≤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 β-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.
UR - http://www.scopus.com/inward/record.url?scp=85008318951&partnerID=8YFLogxK
U2 - 10.1067/mhj.2002.125326
DO - 10.1067/mhj.2002.125326
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AN - SCOPUS:85008318951
SN - 0002-8703
VL - 144
SP - 597
EP - 607
JO - American Heart Journal
JF - American Heart Journal
IS - 4
ER -
