Key result
This paper is a study protocol for the DanAF trial, which will evaluate whether a lenient rate control strategy (<110 bpm) improves quality of life compared to a strict rate control strategy (<80 bpm) in patients with atrial fibrillation.
Why the study?
The optimal heart rate target in patients with atrial fibrillation remains disputed despite the results of the RACE II trial.
Does a lenient rate control strategy improve quality of life compared to a strict rate control strategy in outpatients with persistent or permanent atrial fibrillation?
RCT (n=350)
Double-blind (treatment providers unblinded)
1:1
Yes
Does a lenient rate control strategy improve quality of life compared to a strict rate control strategy in outpatients with persistent or permanent atrial fibrillation?
This protocol outlines a randomized trial to determine if lenient rate control improves quality of life compared to strict rate control in patients with persistent or permanent atrial fibrillation.
Answers are grounded in this paper and cite their sources.
Optimal AF rate targets remain uncertain; DanAF protocol leaves open whether strict or lenient control improves outcomes.
INTRODUCTION: Atrial 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 ANALYSIS: We 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 DISSEMINATION: Ethics 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 NUMBER: NCT04542785.
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Feinberg et al. (2021) conducted an RCT in Persistent or permanent atrial fibrillation (n=350). Lenient rate control strategy vs. Strict rate control strategy (target resting heart rate <80 bpm) was evaluated on Quality of life using the Short Form-36 (SF-36) questionnaire (physical component score). This paper is a study protocol for the DanAF trial, which will evaluate whether a lenient rate control strategy (<110 bpm) improves quality of life compared to a strict rate control strategy (<80 bpm) in patients with atrial fibrillation.
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