Author + information
- Received February 8, 2011
- Revision received May 27, 2011
- Accepted June 21, 2011
- Published online October 18, 2011.
- Hessel F. Groenveld, MD⁎,
- Harry J.G.M. Crijns, MD†,
- Maarten P. Van den Berg, MD⁎,
- Eric Van Sonderen, PhD‡,
- A. Marco Alings, MD§,
- Jan G.P. Tijssen, PhD∥,
- Hans L. Hillege, MD¶,
- Ype S. Tuininga, MD#,
- Dirk J. Van Veldhuisen, MD⁎,
- Adelita V. Ranchor, PhD‡,
- Isabelle C. Van Gelder, MD⁎,⁎⁎,⁎ (, )
- RACE II Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Isabelle C. Van Gelder, Department of Cardiology, Thoraxcenter, University Medical Center Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, the Netherlands
Objectives The aim of this study was to investigate the influence of rate control on quality of life (QOL).
Background The RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation II) trial showed that lenient rate control is not inferior to strict rate control in terms of cardiovascular morbidity and mortality. The influence of stringency of rate control on QOL is unknown.
Methods In RACE II, a total of 614 patients with permanent atrial fibrillation (AF) were randomized to lenient (resting heart rate [HR] <110 beats/min) or strict (resting HR <80 beats/min, HR during moderate exercise <110 beats/min) rate control. QOL was assessed in 437 patients using the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) questionnaire, AF severity scale, and Multidimensional Fatigue Inventory-20 (MFI-20) at baseline, 1 year, and end of study. QOL changes were related to patient characteristics.
Results Median follow-up was 3 years. Mean age was 68 ± 8 years, and 66% were males. At the end of follow-up, all SF-36 subscales were comparable between both groups. The AF severity scale was similar at baseline and end of study. At baseline and at end of study there were no differences in the MFI-20 subscales between the 2 groups. Symptoms at baseline, younger age, and less severe underlying disease, rather than assigned therapy or heart rate, were associated with QOL improvements. Female sex and cardiovascular endpoints during the study were associated with worsening of QOL.
Conclusions Stringency of heart rate control does not influence QOL. Instead, symptoms, sex, age, and severity of the underlying disease influence QOL. (Rate Control Efficacy in Permanent Atrial Fibrillation; NCT00392613)
This study was supported by the Netherlands Heart Foundation (grant 2003B118). A full list of the RACE II Investigators can be found in Van Gelder et al. (11). Dr. Ailings is on the advisory board of Bayer, Boehringer Ingelheim, MSD, and Sanofi-Aventis. Dr. Van Veldhuisen has board memberships with Amgen and Pfizer; and receives consultancy fees from Medtronic, Biotronik, Alere, and Vifor. Dr. Van Gelder receives consulting fees from Sanofi-Aventis, Boehringer Ingelheim, and Cardiome; receives grant support from Medtronic, Biotronik, and St. Jude Medical; and receives lecture fees from Sanofi-Aventis, Boehringer Ingelheim, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 8, 2011.
- Revision received May 27, 2011.
- Accepted June 21, 2011.
- American College of Cardiology Foundation