Tirzepatide trial to evaluate atrial fibrillation burden reduction post-ablation in overweight/obese patients

Atrial fibrillation (AF) is a common arrhythmia, with obesity being a significant risk factor for its development and recurrence post-ablation. Current standard-of-care often falls short in addressing the underlying metabolic drivers of AF progression. GLP-1 and GIP receptor agonists, like tirzepatide, have demonstrated substantial weight loss and cardiovascular benefits, suggesting a potential role in mitigating AF burden by improving metabolic health and reducing inflammation. This trial aims to explore this therapeutic gap.

This multi-center, open-label, endpoint-blinded randomized controlled trial (RCT) will enroll adults aged 18-80 years with persistent AF and BMI ≥25 kg/m² scheduled for de novo catheter ablation. Participants are randomized 1:1 to receive either tirzepatide 2.5 mg once weekly subcutaneously or standard care alone. The tirzepatide group will receive treatment for approximately 4 months, starting 4 weeks pre-ablation and continuing for 3 months post-ablation. Follow-up assessments are scheduled at 1, 2, 3, 6, and 12 months post-ablation, with detailed assessment of AF burden, AF recurrence, echocardiographic parameters, metabolic profile, quality of life, and safety events.

This is a clinical trial protocol, and results are not yet available. Researchers plan to measure the primary endpoint of AF burden at 3 months after de novo catheter ablation, quantified by 7-day continuous ECG patch monitoring. Secondary endpoints include assessing AF recurrence and major cardiovascular events during 12 months of follow-up. The study will also evaluate changes in body weight, metabolic parameters (e.g., blood glucose, lipids), and echocardiographic parameters. Quality of life will be measured using the AFEQT questionnaire, and safety events will be meticulously monitored throughout the trial. The hypothesis is that tirzepatide will lead to greater weight loss and improved metabolic profiles, which in turn will reduce AF burden and recurrence compared to standard care alone.