Feasibility study of Glucagon-like peptide-1 analogues for the optimization of Outcomes in obese patients undergoing AbLation for Atrial Fibrillation (GOAL-AF) protocol

Abstract

BackgroundCatheter ablation for atrial fibrillation is recommended for symptomatic patients after failed medical therapy. Ablation has a higher failure rate in obese patients, and both the prevalence of atrial fibrillation and obesity are increasingly globally. The outcome of ablation can be improved if obese patients can achieve goal-oriented weight reduction prior to ablation. Conventional weight loss strategies, however, can be difficult to access and can delay ablation, thereby risking a lower chance of maintaining sinus rhythm. Effective weight-loss medications, such as the glucagon-like peptide inhibitor-1 drugs, offer the potential for incremental impact on weight loss over a shorter period of time as a bridging therapy. The aim of this study is to assess the feasibility of using liraglutide, a glucagon-like peptide inhibitor-1, in producing weight loss in obese patients before catheter ablation.MethodsThe study is an open-label, uncontrolled, prospective single-centre feasibility study of daily liraglutide injections in the treatment of obese patients for at least 13 weeks before and 52 weeks after AF ablation. Adult patients with symptomatic AF whose body mass index ≥ 30 will be recruited from those planning to undergo ablation. Feasibility will be determined based on the recruitment rate, adherence to the medication, and the amount of weight loss achieved over the study period. Exploratory outcomes include changes in atrial structure, function, and fibrosis with weight loss evaluated by cardiac magnetic resonance imaging, electroanatomic mapping, and patient-reported outcome measure.DiscussionThis study will allow us to determine whether the use of liraglutide in obese patients with atrial fibrillation undergoing ablation is feasible with adequate recruitment. The additional information on adherence and average weight loss over the study period will inform the design of a future definitive randomized controlled trial.Trial registrationClinicalTrials.gov (NCT05221229). Registered on 2 February 2022.Trial fundingMetchley Park Medical Society and University of Birmingham Starter Fellowship, British Heart Foundation Accelerator Grant, Abbott Investigator-Initiated Study Grant.