SEMAGLUTIDE for Obesity | Atrial fibrillation

Inclusion criteria

• {"criterion_text":"- Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF\n- Age ≥ 18\n- 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)\n- Scheduled electrical cardioversion (ECV)\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Permanent AF\n- Acute coronary syndrome <6 months\n- Severe (grade III) valvular disease\n- Heart failure NYHA class III-IV\n- Participation in another investigational drug or device study in the past 30 days (registry enrollment is allowed)\n- 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\n- Female who is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.\n- Secondary AF due to thyrotoxicosis, infection (e.g. pneumonia) or post-cardiothoracic surgery\n- Current or previous treatment with amiodaron\n- HbA1c ≥ 48 mmol/L, <3 months prior to randomization\n- History of diabetes mellitus type 1 or 2\n- Prior bariatric surgery\n- Use of other anti-obesity medication, <3 months prior to enrollment\n- Contra-indication for, or prior use of a GLP1-receptor agonist\n- History of chronic pancreatitis or acute pancreatitis <6 months"}

Primary endpoints

• {"endpoint_text":"- For all patients, the one-year rhythm outcome status is ranked according to severity, from the most severe to the least severe outcome, as follows: Arrhythmic death while on Vaughn-Williams class I or III (VW-I/III) anti-arrhythmic drugs (AAD) In Atrial fibrillation (AF) after pulmonary vein isolation (PVI) In AF and on VW-I/III AAD In AF and not on VW-I/III AAD In Sinus Rhythm (SR) after PVI In SR and on VW-I/III AAD In SR and not on VW-I/III AAD","definition_or_measurement_approach":"One-year rhythm outcome status ranked by severity as listed; assessed at one year."}
• {"endpoint_text":"- The second primary endpoint of the trial is the occurrence of any of the following at or within 12 months after randomization Persistent AF on the ECG at the 12-month visit Catheter ablation for AF Arrhythmic death Any serious adverse event due to an anti-arrhythmic drug This second primary endpoint will be statistically assessed as a binary (yes/no) variable.","definition_or_measurement_approach":"Occurrence of any listed events at or within 12 months after randomization; analysed as a binary (yes/no) variable."}

Secondary endpoints

• {"endpoint_text":"- Change in AF related symptoms measured by the modified EHRA score between the index visit and at 12 months after the index visit.","definition_or_measurement_approach":"Measured by the modified EHRA score between index visit and 12 months."}
• {"endpoint_text":"- Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit.","definition_or_measurement_approach":"Measured by EQ-5D-5L between index visit and 12 months."}
• {"endpoint_text":"- Number of hospitalizations because of an AF recurrence.","definition_or_measurement_approach":"Count of hospitalizations due to AF recurrence during study period."}
• {"endpoint_text":"- Number of unscheduled hospital visits because of adverse events of AAD.","definition_or_measurement_approach":"Count of unscheduled hospital visits due to adverse events of anti-arrhythmic drugs."}
• {"endpoint_text":"- Number of scheduled electrical cardioversions.","definition_or_measurement_approach":"Count of scheduled electrical cardioversions during follow-up."}
• {"endpoint_text":"- Number of unscheduled electrical cardioversions.","definition_or_measurement_approach":"Count of unscheduled electrical cardioversions during follow-up."}
• {"endpoint_text":"- Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs).","definition_or_measurement_approach":"Count of intravenous chemical cardioversions using VW class I drugs."}
• {"endpoint_text":"- Total number of unscheduled cardioverions","definition_or_measurement_approach":"Total count of unscheduled cardioversions."}
• {"endpoint_text":"- Change in waist circumference, measured in cm (time frame: week 0 and 52).","definition_or_measurement_approach":"Waist circumference measured in cm at baseline (week 0) and week 52."}
• {"endpoint_text":"- Change in weight, measured in % and kg (time frame: week 0 and 52)","definition_or_measurement_approach":"Weight change measured in percent and kilograms at baseline and week 52."}
• {"endpoint_text":"- Change in BMI, measured in kg/m2 (time frame: week 0 and 52).","definition_or_measurement_approach":"BMI measured in kg/m2 at baseline and week 52."}
• {"endpoint_text":"- Change in systolic blood pressure, measured in mmHg (time frame: week 0 and 52).","definition_or_measurement_approach":"Systolic BP measured in mmHg at baseline and week 52."}
• {"endpoint_text":"- Change in diastolic blood pressure, measured in mmHg (time frame: week 0 and 52).","definition_or_measurement_approach":"Diastolic BP measured in mmHg at baseline and week 52."}
• {"endpoint_text":"- Change in HbA1c, measured in % and mmol/L (time frame: week 0 and 52)","definition_or_measurement_approach":"HbA1c measured in % and mmol/L at baseline and week 52."}
• {"endpoint_text":"- Change in lipids (total cholesterol, LDL, HDL and triglycerides), measured in mmol/L (time frame: week 0 and 52)","definition_or_measurement_approach":"Lipid panel measured in mmol/L at baseline and week 52."}
• {"endpoint_text":"- Change in CRP, measured in mg/L (time frame: week 0 and 52).","definition_or_measurement_approach":"CRP measured in mg/L at baseline and week 52."}
• {"endpoint_text":"- Change in NT-pro BNP, measured pmol/L (time frame: week 0 and 52)","definition_or_measurement_approach":"NT-proBNP measured in pmol/L at baseline and week 52."}
• {"endpoint_text":"- Change in work productivity measured by the Work Productivity and Activity Index, between the index visit and at 12 months after the index visit.","definition_or_measurement_approach":"Work productivity measured by WPAI between index visit and 12 months."}
• {"endpoint_text":"- Change in exercise motivation using the Behavioral Regulation and Exercise Questionnaire 2 between the index visit and at 12 months after the index visit.","definition_or_measurement_approach":"Exercise motivation measured by BREQ-2 between index visit and 12 months."}
• {"endpoint_text":"- Difference in total cost of all healthcare expenditures related to the management of atrial fibrillation, in Euros.","definition_or_measurement_approach":"Health economic comparison of total AF-related healthcare expenditures (in Euros)."}

Methods

• K1_Recruitment arrangements document listed (recruitment arrangements for publication) - details in submitted recruitment document (document present in CTIS).
• K2_Recruitment material_Invitation digital PIF (title indicates a digital invitation Patient Information Form) - digital invitation method explicitly referenced by document title.

Netherlands

Earliest CTIS Part Ii Submission Date

31-05-2024

Latest Decision Or Authorization Date

07-05-2025

Processing Time Days

341

Number Of Sites

22

Number Of Participants

280

Primary sponsor

Full Name

Stichting Rijnstate Ziekenhuis

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands