Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Rijnstate Hospital
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
