Trial DesignRAte Control Efficacy in permanent atrial fibrillation: a comparison between lenient versus strict rate control in patients with and without heart failure. Background, aims, and design of RACE II
Section snippets
Rate control may be adopted as first choice therapy in atrial fibrillation
Permanent atrial fibrillation (AF) is not a benign disease.1 It may cause symptoms and is associated with thromboembolic complications. Some patients with longer-lasting AF may develop left ventricular dysfunction, even those without underlying heart disease (tachycardiomyopathy). The AFFIRM, RACE, PIAF, and STAF studies and others (HOT CAFÉ) established that morbidity and mortality was comparable between rate and rhythm control therapy.2, 3, 4, 5, 6 As a result, rate control may now be adopted
Study design and methods
The RACE II study (Figure 1) is being conducted in 29 centers in The Netherlands. The institutional review board of each institution approved the study, and all patients gave written informed consent. Recruitment began in January 2005, randomization is expected to be concluded in June 2006, and follow-up will be terminated in June 2008. At present, 375 patients have been included. The trial is funded by grants from the Netherlands Heart Foundation and the Interuniversity Cardiology Institute,
Sample size determination and statistical analysis
The primary aim is to show noninferiority of lenient rate control as compared with strict rate control in terms of the primary end point. The expected incidence of the primary end point in both groups is 25%. Noninferiority will be established if it is shown that the absolute difference in the incidence of the primary end point does not exceed 2.5% (relative difference is ≤10%). To achieve a power of at least 80% with a 95% confidence limit (1-sided test with α = 5%), 250 patients in each
Conclusions
Rate control is now first choice therapy in many patients with AF. However, the optimal heart rate during AF is unknown. The ACC/AHA/ESC guidelines recommend a heart rate between 60 and 80 bpm in rest and 90 and 120 bpm during moderate exercise. Although, these recommendations are arbitrary and are not evidence based. The results of this trial should provide information concerning two widely applicable treatment strategies in typical permanent AF patients. Clinical decision making will be
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Cited by (73)
Impact of heart rate on adverse events in patients with non-valvular atrial fibrillation: Subanalysis of the J-RHYTHM Registry
2022, IJC Heart and VasculatureCitation Excerpt :Thus, the impact of HR on adverse events in patients with NVAF remains controversial [4,17,18]. In the present study, first of all, we evaluated the impact of baseline HR on adverse events, since baseline HR was often analyzed in previous studies [17–19]. However, our results demonstrated that the baseline HR quartiles did not show a significant trend for any event across study groups (Table 2).
Target heart rate in heart failure with reduced ejection fraction and atrial fibrillation: Goldilocks zone
2022, American Heart Journal Plus: Cardiology Research and PracticeRate control in atrial fibrillation
2016, The LancetPACES/HRS expert consensus statement on the recognition and management of arrhythmias in adult congenital heart disease: Developed in partnership between the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Endorsed by the governing bodies of PACES, HRS, the American College of Cardiology (ACC), the American Heart Association (AHA), the European Heart Rhythm Association (EHRA), the Canadian Heart Rhythm Society (CHRS), and the International Society for Adult Congenital Heart Disease (ISACHD)
2014, Heart RhythmCitation Excerpt :Clinical trials in adults with and without heart failure have included targets such as a maximum heart rate of 80 bpm at rest and <110 bpm on exertion.126,127,132 However, more lenient objectives in patients without CHD, including a mean resting heart rate >80 bpm, have been associated with similar outcomes.133,134 As such, some management guidelines have revised the recommended resting ventricular rate target to 100 bpm.135
PACES/HRS Expert Consensus Statement on the Recognition and Management of Arrhythmias in Adult Congenital Heart Disease
2014, Canadian Journal of CardiologyDigoxin in patients with permanent atrial fibrillation: Data from the RACE II study
2014, Heart RhythmCitation Excerpt :Patients were stratified by the use of digoxin after the dose-adjustment phase. The study design, patient characteristics, and results of the RACE II trial have been published previously.11,14,17–20 In short, the RACE II trial was a randomized multicenter study comparing long-term effects of lenient vs strict rate control on morbidity and mortality in 614 patients with permanent AF in the Netherlands.
The study is supported by NHS (Netherlands Heart Foundation, 2003B118), ICIN (Interuniversity Cardiology Institute, The Netherlands), WCN (Working Group Cardiology, The Netherlands); AstraZeneca, Biotronik, Guidant, Medtronic, Roche, and Vitatron (all The Netherlands); and Sanofi-Aventis France.