Status:
RECRUITING
DUTCH Weight Control in Atrial Fibrillation Study
Lead Sponsor:
Rijnstate Hospital
Conditions:
Atrial Fibrillation
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Quantify the effect of an innovative weight loss management on rhythm control.
Detailed Description
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-ce...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06184633
Start Date
July 21 2024
End Date
May 1 2027
Last Update
September 19 2024
Active Locations (1)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands