Lenient rate control versus strict rate control for atrial fibrillation: a protocol for the Danish Atrial Fibrillation (DanAF) randomised clinical trial
Lenient rate control versus strict rate control for atrial fibrillation: a protocol for the Danish Atrial Fibrillation (DanAF) randomised clinical trial
Blog Article
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 u11-200ps 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, bushranger awning 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.