Lenient rate control versus strict rate control for atrial fibrillation: A protocol for the Danish Atrial Fibrillation (DanAF) randomised clinical trial
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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.
| Original language | English |
|---|---|
| Article number | 044744 |
| Journal | BMJ Open |
| Volume | 11 |
| Issue number | 3 |
| Number of pages | 9 |
| ISSN | 2044-6055 |
| DOIs | |
| Publication status | Published - 31 Mar 2021 |
Bibliographical note
Funding Information:
Holbaek University Hospital Odense University Hospital Hvidovre University Hospital Region Zealand University Hospital - Roskilde Region of Southern Denmark and Region Zealand joint research fund 2018 The Danish Heart foundation grant number 19-R134-A8959-22123 The University of Southern Denmark A.P. Moeller Foundation
Funding Information:
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.
Funding Information:
Funding The trial was initiated by clinicians at the participating hospitals. The research salary for research nurses is partly funded by the Region of Southern Denmark and Region Zealand joint research fund 2018 for year 1. The salary of the lead author for years 2 and 3 are provided by the Danish Heart foundation grant number 19-R134-A8959-22123. The salary for year 1 is granted by the University of Southern Denmark. The participating departments support the trial by dedicating work hours of the other investigators, supportive staff, logistical support and administrative support. The trial is investigator initiated. Holbaek Hospital is the sponsor, and the Region Zealand is the data controller. The study sponsors and funders had no influence on design; collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication. The Danish Heart Foundation requires to be notified by email when a publication is accepted. Roles and responsibilities of additional parties are described in supplementary file 8.
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- adult cardiology, cardiology, pacing & electrophysiology
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