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

• Published in: Current controlled trials in cardiovascular medicine 2023-04, Vol.24 (1), p.250-250, Article 250
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Analysis; Anticoagulants; Atrial fibrillation; Atrial Fibrillation - complications; Atrial Fibrillation - diagnosis; Atrial Fibrillation - drug therapy; Cardiac arrhythmia; Cardioversion; Care and treatment; Consent; Denmark; Diagnosis; Ejection fraction; Electrocardiography; Heart beat; Heart failure; Heart rate; Hospitalization; Humans; Hypotheses; International conferences; Mortality; Patients; Quality of life; Questionnaires; Randomized trial; Rate control; Research Design; Statistical analysis; Statistical analysis plan; Stroke Volume; Treatment Outcome; Update; Ventricular Function, Left
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07247-7

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. 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