BridgeMD
DUTCH-WAIST
EU CTIS ID: 2022-501392-81-00
What this study is testing
The primary objective of this randomized controlled trial is to demonstrate superiority of once-weekly 2.4 mg semaglutide s.c. over placebo in achieving sinus rhythm at one year in patients with obesity and first detected, symptomatic persistent atrial fibrillation (AF).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.