DUTCH Weight Control in Atrial Fibrillation Study

Rationale: Weight reduction promotes reversed atrial remodeling in obese AF patients.

Objective: Quantify the effect of an innovative weight loss management on rhythm control.

Study design: Multi-center, double-blind, randomized, parallel group, placebo-controlled trial of semaglutide 2.4 mg versus placebo.

Study population: Adults with obesity and new onset persistent AF scheduled for electrical cardioversion.

Intervention: semaglutide 2.4 mg subcutaneous (s.c.) once weekly (index) compared to placebo (control), at the background of standard obesity treatment (combined lifestyle intervention) and cardiology follow-up management in both arms.

Main study parameters/endpoints: The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 7 mutually exclusive outcomes hierarchically ranked from worst to best are:

* Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)\* * AF despite pulmonary vein isolation * AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) * AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) * Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation * Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) * Sinus rhythm on the 12-lead ECG without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) and without a pulmonary vein isolation

* When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.

• Change in AF related symptoms measured by the modified EHRA classification between the index visit and at 12 months after the index visit. [Срок оценки: week 0 and 52]
• Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit. [Срок оценки: week 0 and 52]
• Number of hospitalizations because of an AF recurrence. [Срок оценки: week 0-52]
• Number of unscheduled hospital visits because of adverse events of AAD. [Срок оценки: week 0-52]
• Number of scheduled electrical cardioversions. [Срок оценки: week 0-52]
• Number of unscheduled electrical cardioversions. [Срок оценки: week 0-52]
• Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs). [Срок оценки: week 0-52]
• Total number of unscheduled cardioverions. [Срок оценки: week 0-52]
• Change in waist circumference, measured in cm [Срок оценки: week 0 and 52]
• Change in weight, measured in % and kg [Срок оценки: week 0 and 52]
• Change in BMI, measured in kg/m2 [Срок оценки: week 0 and 52]