American Heart Journal
Volume 152, Issue 3 , Pages 420-426, September 2006

RAte 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

  • Isabelle C. Van Gelder, MD

      Affiliations

    • University Medical Center Groningen, University of Groningen, The Netherlands
    • Corresponding Author InformationReprint requests: Isabelle C. Van Gelder, MD, Department of Cardiology, Thoraxcenter, University Medical Center Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands.
    • ,
  • Dirk J. Van Veldhuisen, MD

      Affiliations

    • University Medical Center Groningen, University of Groningen, The Netherlands
    • ,
  • Harry J.G.M. Crijns, MD

      Affiliations

    • University Hospital Maastricht, The Netherlands
    • ,
  • Ype S. Tuininga, MD

      Affiliations

    • WCN Deventer Hospital, The Netherlands
    • ,
  • Jan G.P. Tijssen, PhD

      Affiliations

    • Academical Medical Center, Amsterdam, The Netherlands
    • ,
  • A. Marco Alings, MD

      Affiliations

    • WCN, Amphia Hospital Breda, Breda, The Netherlands
    • ,
  • Hans A. Bosker, MD

      Affiliations

    • WCN, Rijnstate Hospital, Arnhem, The Netherlands
    • ,
  • Jan H. Cornel, MD

      Affiliations

    • WCN, Alkmaar, The Netherlands
    • ,
  • Otto Kamp, MD

      Affiliations

    • VU University Medical Center, Amsterdam, The Netherlands
    • ,
  • Nic J.G.M. Veeger, MSc

      Affiliations

    • Trial Coordination Center, University Medical Center Groningen, Groningen, The Netherlands
    • ,
  • Meint Volbeda, MD

      Affiliations

    • University Medical Center Groningen, University of Groningen, The Netherlands
    • ,
  • Michiel Rienstra, MD

      Affiliations

    • University Medical Center Groningen, University of Groningen, The Netherlands
    • ,
  • Adelita V. Ranchor, PhD

      Affiliations

    • Northern Center for Healthcare Research, Groningen, The Netherlands
    • ,
  • Elisabeth M. TenVergert, PhD

      Affiliations

    • Office for Medical Technology Assessment, University Medical Center Groningen, Groningen, The Netherlands
    • ,
  • Maarten P. Van Den Berg, MD

      Affiliations

    • University Medical Center Groningen, University of Groningen, The Netherlands

Received 4 November 2005; accepted 27 February 2006. published online 30 June 2006.

Background

Recent studies demonstrated that rate control is an acceptable alternative for rhythm control in patients with persistent atrial fibrillation (AF). However, optimal heart rate during AF is still unknown.

Objective

To show that in patients with permanent AF, lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality, morbidity, neurohormonal activation, New York Heart Association class for heart failure, left ventricular function, left atrial size, quality of life, and costs.

Methods

The RACE II study is a prospective multicenter trial in The Netherlands that will randomize 500 patients with permanent AF (≤12 months) to strict or lenient rate control. Strict rate control is defined as a mean resting heart rate <80 beats per minute (bpm) and heart rate during minor exercise <110 bpm. After reaching the target, a 24-hour Holter monitoring will be performed. If necessary, drug dose reduction and/or pacemaker implantation will be performed. Lenient rate control is defined as a resting heart rate <110 bpm. Patients will be seen after 1, 2, and 3 months (for titration of rate control drugs) and yearly thereafter. We anticipate a 25% 2.5-year cardiovascular morbidity and mortality in both groups.

Results

Enrollment started in January 2005 in 29 centers in The Netherlands and is expected to be concluded in June 2006. Follow-up will be at least 2 years with a maximum of 3 years.

Conclusion

This study should provide data how to treat patients with permanent AF.

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 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.

PII: S0002-8703(06)00172-4

doi:10.1016/j.ahj.2006.02.033

American Heart Journal
Volume 152, Issue 3 , Pages 420-426, September 2006

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