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DUTCH Weight Control in Atrial Fibrillation Study
RECRUITINGPhase 4Sponsored by Rijnstate Hospital
Actively Recruiting
PhasePhase 4
SponsorRijnstate Hospital
Started2024-07-21
Est. completion2026-05-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06184633
Summary
Quantify the effect of an innovative weight loss management on rhythm control.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions4
Atrial FibrillationHeart DiseaseObesityWeight Loss
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Actively Recruiting
PhasePhase 4
SponsorRijnstate Hospital
Started2024-07-21
Est. completion2026-05-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06184633