DUTCH Weight Control in Atrial Fibrillation Study
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; BMI ≥30 required; conditions: Atrial Fibrillation; Obesity; Weight Loss
- Interventions
- Semaglutide 3.2 MG/ML; Placebo
- Conditions
- Atrial Fibrillation; Obesity; Weight Loss
- Phase and size
- Phase 4 · 280 participants
- Dates
- Start 2024-07-21
Primary completion 2026-05-01 - Sponsor
- Rijnstate Hospital (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- 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 outcomeAt 1 year follow-up
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.