scholarly journals Lenient rate control versus strict rate control for atrial fibrillation: a protocol for the Danish Atrial Fibrillation (DanAF) randomised clinical trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044744
Author(s):  
Joshua Buron Feinberg ◽  
Michael Hecht Olsen ◽  
Axel Brandes ◽  
llan Raymond ◽  
Walter Bjørn Nielsen ◽  
...  

IntroductionAtrial fibrillation is the most common heart arrhythmia with a prevalence of approximately 2% in the western world. Atrial fibrillation is associated with an increased risk of death and morbidity. In many patients, a rate control strategy is recommended. The optimal heart rate target is disputed despite the results of the the RAte Control Efficacy in permanent atrial fibrillation: a comparison between lenient vs strict rate control II (RACE II) trial.Our primary objective will be to investigate the effect of lenient rate control strategy (<110 beats per minute (bpm) at rest) compared with strict rate control strategy (<80 bpm at rest) on quality of life in patients with persistent or permanent atrial fibrillation.Methods and analysisWe plan a two-group, superiority randomised clinical trial. 350 outpatients with persistent or permanent atrial fibrillation will be recruited from four hospitals, across three regions in Denmark. Participants will be randomised 1:1 to a lenient medical rate control strategy (<110 bpm at rest) or a strict medical rate control strategy (<80 bpm at rest). The recruitment phase is planned to be 2 years with 3 years of follow-up. Recruitment is expected to start in January 2021. The primary outcome will be quality of life using the Short Form-36 (SF-36) questionnaire (physical component score). Secondary outcomes will be days alive outside hospital, symptom control using the Atrial Fibrillation Effect on Quality of Life, quality of life using the SF-36 questionnaire (mental component score) and serious adverse events. The primary assessment time point for all outcomes will be 1 year after randomisation.Ethics and disseminationEthics approval was obtained through the ethics committee in Region Zealand. The design and findings will be published in peer-reviewed journals as well as be made available on ClinicalTrials.gov.Trial registration numberNCT04542785.

2011 ◽  
Vol 58 (17) ◽  
pp. 1795-1803 ◽  
Author(s):  
Hessel F. Groenveld ◽  
Harry J.G.M. Crijns ◽  
Maarten P. Van den Berg ◽  
Eric Van Sonderen ◽  
A. Marco Alings ◽  
...  

2006 ◽  
Vol 70 (8) ◽  
pp. 965-970 ◽  
Author(s):  
Takayuki Tsuneda ◽  
Takeshi Yamashita ◽  
Masatake Fukunami ◽  
Koichiro Kumagai ◽  
Shin-ichi Niwano ◽  
...  

EP Europace ◽  
2019 ◽  
Vol 22 (11) ◽  
pp. 1619-1627 ◽  
Author(s):  
Mariëlle Kloosterman ◽  
Harry J G M Crijns ◽  
Bart A Mulder ◽  
Hessel F Groenveld ◽  
Dirk J Van Veldhuisen ◽  
...  

Abstract Aims Atrial fibrillation (AF) risk factors translate into disease progression. Whether this affects women and men differently is unclear. We aimed to investigate sex differences in risk factors, outcome, and quality of life (QoL) in permanent AF patients. Methods and results The Rate Control Efficacy in Permanent Atrial Fibrillation (RACE II) randomized 614 patients, 211 women and 403 men, to lenient or strict rate control. In this post hoc analysis risk factors, cardiovascular events during 3-year follow-up (cardiovascular death, heart failure hospitalization, stroke, systemic embolism, bleeding, and life-threatening arrhythmic events), outcome parameters, and QoL were compared between the sexes. Women were older (71 ± 7 vs. 66 ± 8 years, P &lt; 0.001), had more hypertension (70 vs. 57%, P = 0.002), and heart failure with preserved ejection fraction (36 vs. 17%, P &lt; 0.001), but less coronary artery disease (13 vs. 21%, P = 0.02). Women had more risk factors (3.7 ± 1.2 vs. 2.9 ± 1.4, P &lt; 0.001) Cardiovascular events occurred in 46 (22%) women and 59 (15%) men (P = 0.03). Women had a 1.52 times [95% confidence interval (CI) 1.03–2.24] higher yearly cardiovascular event-rate [8.2% (6.0–10.9) vs. 5.4% (4.1–6.9), P = 0.03], but this was no longer significant after adjusting for the number of underlying risk factors. Women had reduced QoL, irrespective of age and heart rate but negatively influenced by their risk factors. Conclusion In this permanent AF population, women had more accumulation of AF risk factors than men. The observed higher cardiovascular event rate in women was no longer significant after adjusting for the number of risk factors. Further, QoL was negatively influenced by the higher number of risk factors in women. This suggests that sex differences may be driven by the greater risk factor burden in women.


2018 ◽  
Vol 88 (2) ◽  
Author(s):  
Stefano Fumagalli ◽  
Serena Boni ◽  
Simone Pupo ◽  
Marta Migliorini ◽  
Irene Marozzi ◽  
...  

Atrial fibrillation (AF) is the most frequent arrhythmia in elderly people. Findings derived from clinical trials seem to demonstrate that a rate-control strategy of AF in aged patients improves prognosis if compared to a rhythm-control one. However, epidemiological studies concordantly show that the arrhythmia is associated to increased hospitalization and mortality rates. In last years, the proportion of patients admitted to hospital for AF has progressively increased; this trend is observed in subjects >75 and >85 years, while no change was found in younger cohorts. Importantly, in aged individuals, probably because of the loss of atrial activity, the increase of heart rate and the irregularity of RR intervals, AF begins a vicious cycle, leading from heart failure, through the compromise of functional and neurocognitive status, to overt disability, dementia and increased mortality. Evidence specifically aimed at clarifying the effects of arrhythmia management on outcomes characteristic of aged people is completely lacking. In the elderly, the question regarding the effects of a rate- or a rhythm-control strategy of AF should be considered as an aspect of a more complex strategy, addressed to reduce disability and hospitalizations, and to improve quality of life and survival.


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