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. 2021 Mar 31;11(3):e044744.
doi: 10.1136/bmjopen-2020-044744.

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

Joshua Buron Feinberg  1   2 , Michael Hecht Olsen  3   2 , Axel Brandes  4 , Llan Raymond  3 , Walter Bjørn Nielsen  3 , Emil Eik Nielsen  3   5 , Frank Stensgaard-Hansen  3 , Ulrik Dixen  6 , Ole Dyg Pedersen  7 , Uffe Jakob Ortved Gang  7 , Christian Gluud  2   5 , Janus Christian Jakobsen  2   5
Affiliations

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

Joshua Buron Feinberg et al. BMJ Open. .

Abstract

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.

Keywords: adult cardiology; cardiology; pacing & electrophysiology.

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Conflict of interest statement

Competing interests: JBF (PI), IR, WB, EEN, FS-H, ODP, UG, CG and JCJ report no competing interests. MHO reports grants from Novo Nordic Foundation outside the submitted work. AB reports personal fees from Bayer, grants from Biotronik, personal fees from Boehringer Ingelheim, personal fees from Bristol-Myers Squibb, personal fees from MSD, grants from Theravance, outside the submitted work. UD reports a research grant from Bayer, personal fees from Pfizer, member of advisory board for Boehringer Ingelheim, member of advisory board for Merck, outside the submitted work.

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