DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial

U1111-1275-9989

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

2024-05-01

2026-05-01

2027-05-01

Not yet recruiting

Early phase I

280

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}

2024-01-08