Study of Semaglutide and Lifestyle Changes for Weight Control in Adults with Obesity and New Persistent Atrial Fibrillation Undergoing Electrical Cardioversion

What this Trial Is About

Researchers are evaluating how an innovative weight loss management approach affects rhythm control in adults with obesity and new onset persistent atrial fibrillation AF who are scheduled for electrical cardioversion. This multi-center, double-blind, randomized, parallel group, placebo-controlled trial compares semaglutide 2.4 mg subcutaneous injections once weekly versus placebo, both combined with standard lifestyle interventions and cardiology follow-up. The study aims to measure the impact of weight reduction on reversing atrial remodeling and improving heart rhythm. Participants receive either semaglutide injections plus a combined lifestyle intervention or placebo injections plus the same lifestyle program. Both groups are monitored under cardiology care. The study period includes treatment and follow-up for 12 months, during which the primary clinical efficacy is evaluated using a seven-point scale that ranks heart rhythm outcomes from worst to best, focusing on arrhythmic death, presence of AF despite treatments, and sinus rhythm with or without medications or procedures. Throughout the study, participants undergo regular assessments including rhythm monitoring by 12-lead ECG, symptom evaluation with the modified EHRA classification, quality of life measurement using the EQ-5D-5L, and tracking of hospitalizations and cardioversions related to AF. Additional measures include changes in waist circumference, weight, and body mass index over the 12-month period. Safety and adherence are monitored continuously, with the main outcome assessed at one year from enrollment.

DUTCH Weight Control in Atrial Fibrillation Study