DUTCH Weight Control in Atrial Fibrillation Study - 2022-501392-81-00

Stichting Rijnstate Ziekenhuis0 个研究点目标入组 280 人开始时间: 2024年3月1日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•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 electrical cardioversion (ECV), Written informed consent

•Permanent AF, Acute coronary syndrome <6 months, Severe (grade III) valvular disease, 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., Secondary AF 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

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