dutch weight control in atrial fibrillation study

Conditions: Atrial Fibrillation; Obesity; Weight Loss

Summary: quantify the effect of an innovative weight loss management on rhythm control.

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.

Eligibility criteria:
inclusion criteria: * symptomatic, first detected (at maximum 6 months prior to enrollment) persistent af - * age ≥ 18 * obesity, as defined as: * bmi ≥ 30 kg/m2, or * bmi ≥27 kg/m2 with the presence of at least one weight related comorbidity (treated or untreated, e.g. hypertension, dyslipidaemia, obstructive sleep apnea, cardiovascular disease) * scheduled ecv * written informed consent exclusion criteria: * permanent af * secondary af, i.e. due to thyrotoxicosis, infection (e.g. pneumonia) or post-(cardiothoracic) surgery * current or previous treatment with amiodaron * hba1c ≥ 48 mmol/l, \<3 months prior to randomization * history of diabetes mellitus type 1 or 2 * prior bariatric surgery * use of other anti-obesity medication, \<3 months prior to enrollment * contra-indication for, or prior use of a glp1-receptor agonist * history of chronic pancreatitis or acute pancreatitis \<6 months * acute coronary syndrome \<6 months * severe (grade iii) valvular disease * egfr \<30 ml/min/1.73m2 * heart failure nyha class iii-iv * participation in another investigational drug or device study in the past 30 days (registry enrollment is allowed) * any condition or therapy, which would make the participant unsuitable for the study (e.g. vulnerable, non-compliance) or life-expectancy \<12 months, as judged by the treating physician. * female who is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.