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Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial

BACKGROUND: A key decision in the treatment of atrial fibrillation is choosing between a rhythm control strategy or a rate control strategy as the main strategy. When choosing rate control, the optimal heart rate target is uncertain. The Danish Atrial Fibrillation trial is a randomized, multicenter,...

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Autores principales: Cold, Isak Mazanti, Feinberg, Joshua Buron, Brandes, Axel, Davidsen, Ulla, Dixen, Ulrik, Dominguez, Helena, Gang, Uffe Jakob Ortved, Gluud, Christian, Hadad, Rakin, Kristensen, Kit Engedal, van Le, Doan Tuyet, Nielsen, Emil Eik, Olsen, Michael Hecht, Pedersen, Ole Dyg, Raymond, Ilan Esra, Sajadieh, Ahmad, Soja, Anne Merete Boas, Jakobsen, Janus Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10068144/
https://www.ncbi.nlm.nih.gov/pubmed/37005636
http://dx.doi.org/10.1186/s13063-023-07247-7
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author Cold, Isak Mazanti
Feinberg, Joshua Buron
Brandes, Axel
Davidsen, Ulla
Dixen, Ulrik
Dominguez, Helena
Gang, Uffe Jakob Ortved
Gluud, Christian
Hadad, Rakin
Kristensen, Kit Engedal
van Le, Doan Tuyet
Nielsen, Emil Eik
Olsen, Michael Hecht
Pedersen, Ole Dyg
Raymond, Ilan Esra
Sajadieh, Ahmad
Soja, Anne Merete Boas
Jakobsen, Janus Christian
author_facet Cold, Isak Mazanti
Feinberg, Joshua Buron
Brandes, Axel
Davidsen, Ulla
Dixen, Ulrik
Dominguez, Helena
Gang, Uffe Jakob Ortved
Gluud, Christian
Hadad, Rakin
Kristensen, Kit Engedal
van Le, Doan Tuyet
Nielsen, Emil Eik
Olsen, Michael Hecht
Pedersen, Ole Dyg
Raymond, Ilan Esra
Sajadieh, Ahmad
Soja, Anne Merete Boas
Jakobsen, Janus Christian
author_sort Cold, Isak Mazanti
collection PubMed
description BACKGROUND: A key decision in the treatment of atrial fibrillation is choosing between a rhythm control strategy or a rate control strategy as the main strategy. When choosing rate control, the optimal heart rate target is uncertain. The Danish Atrial Fibrillation trial is a randomized, multicenter, two-group, superiority trial comparing strict rate control versus lenient rate control in patients with either persistent or permanent atrial fibrillation at inclusion. To prevent bias arising from selective reporting and data-driven analyses, we developed a predefined description of the statistical analysis. METHODS: The primary outcome of this trial is the physical component score of the SF-36 questionnaire. A total of 350 participants will be enrolled based on a minimal important difference of 3 points on the physical component score of the SF-36 questionnaire, a standard deviation of 10 points, a statistical power of 80% (beta of 20%), and an acceptable risk of type I error of 5%. All secondary, exploratory, and echocardiographic outcomes will be hypothesis-generating. The analyses of all outcomes will be based on the intention-to-treat principle. We will analyze continuous outcomes using linear regression adjusting for “site,” type of atrial fibrillation at inclusion (persistent/ permanent), left ventricular ejection fraction (≥ 40% or < 40%), and the baseline value of the outcome (all as fixed effects). We define our threshold for statistical significance as a p-value of 0.05 and assessments of clinical significance will be based on the anticipated intervention effects defined in the sample size and power estimations. Thresholds for both statistical and clinical significance will be assessed according to the 5-step procedure proposed by Jakobsen and colleagues. DISCUSSION: This statistical analysis plan will be published prior to enrolment completion and before any data are available and is sought to increase the validity of the DANish Atrial Fibrillation trial. TRIAL REGISTRATION: Clinicaltrials.gov NCT04542785. Registered on Sept 09, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07247-7.
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spelling pubmed-100681442023-04-04 Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial Cold, Isak Mazanti Feinberg, Joshua Buron Brandes, Axel Davidsen, Ulla Dixen, Ulrik Dominguez, Helena Gang, Uffe Jakob Ortved Gluud, Christian Hadad, Rakin Kristensen, Kit Engedal van Le, Doan Tuyet Nielsen, Emil Eik Olsen, Michael Hecht Pedersen, Ole Dyg Raymond, Ilan Esra Sajadieh, Ahmad Soja, Anne Merete Boas Jakobsen, Janus Christian Trials Update BACKGROUND: A key decision in the treatment of atrial fibrillation is choosing between a rhythm control strategy or a rate control strategy as the main strategy. When choosing rate control, the optimal heart rate target is uncertain. The Danish Atrial Fibrillation trial is a randomized, multicenter, two-group, superiority trial comparing strict rate control versus lenient rate control in patients with either persistent or permanent atrial fibrillation at inclusion. To prevent bias arising from selective reporting and data-driven analyses, we developed a predefined description of the statistical analysis. METHODS: The primary outcome of this trial is the physical component score of the SF-36 questionnaire. A total of 350 participants will be enrolled based on a minimal important difference of 3 points on the physical component score of the SF-36 questionnaire, a standard deviation of 10 points, a statistical power of 80% (beta of 20%), and an acceptable risk of type I error of 5%. All secondary, exploratory, and echocardiographic outcomes will be hypothesis-generating. The analyses of all outcomes will be based on the intention-to-treat principle. We will analyze continuous outcomes using linear regression adjusting for “site,” type of atrial fibrillation at inclusion (persistent/ permanent), left ventricular ejection fraction (≥ 40% or < 40%), and the baseline value of the outcome (all as fixed effects). We define our threshold for statistical significance as a p-value of 0.05 and assessments of clinical significance will be based on the anticipated intervention effects defined in the sample size and power estimations. Thresholds for both statistical and clinical significance will be assessed according to the 5-step procedure proposed by Jakobsen and colleagues. DISCUSSION: This statistical analysis plan will be published prior to enrolment completion and before any data are available and is sought to increase the validity of the DANish Atrial Fibrillation trial. TRIAL REGISTRATION: Clinicaltrials.gov NCT04542785. Registered on Sept 09, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07247-7. BioMed Central 2023-04-01 /pmc/articles/PMC10068144/ /pubmed/37005636 http://dx.doi.org/10.1186/s13063-023-07247-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Update
Cold, Isak Mazanti
Feinberg, Joshua Buron
Brandes, Axel
Davidsen, Ulla
Dixen, Ulrik
Dominguez, Helena
Gang, Uffe Jakob Ortved
Gluud, Christian
Hadad, Rakin
Kristensen, Kit Engedal
van Le, Doan Tuyet
Nielsen, Emil Eik
Olsen, Michael Hecht
Pedersen, Ole Dyg
Raymond, Ilan Esra
Sajadieh, Ahmad
Soja, Anne Merete Boas
Jakobsen, Janus Christian
Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial
title Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial
title_full Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial
title_fullStr Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial
title_full_unstemmed Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial
title_short Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial
title_sort lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the danish atrial fibrillation (danaf) randomized clinical trial
topic Update
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10068144/
https://www.ncbi.nlm.nih.gov/pubmed/37005636
http://dx.doi.org/10.1186/s13063-023-07247-7
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