DUTCH Weight Control in Atrial Fibrillation Study
Recruiting · NCT06184633 · Interventional (participants receive a specific treatment) · Lead sponsor: Rijnstate Hospital
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSemaglutide 3.2 MG/ML
What this trial is about
Quantify the effect of an innovative weight loss management on rhythm control.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed.
- Rijnstate Hospital - Arnhem, Gelderland, Netherlands
- Rijnstate Hospital - Arnhem, Gelderland, Netherlands