RecruitingPhase 4NCT06184633
DUTCH Weight Control in Atrial Fibrillation Study
DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial
Sponsor
Rijnstate Hospital
Enrollment
280 participants
Start Date
Jul 21, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Quantify the effect of an innovative weight loss management on rhythm control.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria16
- 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.
Interventions
DRUGSemaglutide 3.2 MG/ML
Intervention arm receives semaglutide in addition to combined lifestyle intervention
DRUGPlacebo
Control arm receives placebo in addition to combined lifestyle intervention
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06184633
Related Trials
A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)
NCT0724708425 locations
Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
NCT070107571 location
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation
NCT0680821732 locations
The CONFORM Pivotal Trial
NCT0514779283 locations
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)
NCT074817471 location