DUTCH Weight Control in Atrial Fibrillation Study

• Status: Not yet recruiting
• Trial end date: 2027-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rijnstate Hospital
• Treatments: Semaglutide

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.