DUTCH Weight Control in Atrial Fibrillation Study

Launched by RIJNSTATE HOSPITAL · Dec 14, 2023

Keywords

ClinConnect Summary

The DUTCH Weight Control in Atrial Fibrillation Study is looking at how a new weight loss program can help manage heart rhythm in people with atrial fibrillation (AF) who are also dealing with obesity. Atrial fibrillation is a condition where the heart beats irregularly, and obesity can make this condition worse. This study is currently recruiting participants who are between 18 and 74 years old and have been diagnosed with persistent AF within the last six months. To qualify, individuals must have a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher if they also have weight-related health issues like high blood pressure or sleep apnea.

Participants in the study will receive support for weight loss while their heart rhythm is monitored. It's important to note that individuals with certain other heart conditions, diabetes, or specific health issues may not be eligible to join. This trial aims to find out if losing weight can improve heart rhythm control, which could lead to better health outcomes for those living with atrial fibrillation. If you or someone you know fits the criteria and is interested, this could be a valuable opportunity to contribute to important health research.

Gender

ALL

Eligibility criteria

• 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.