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A Study of Semaglutide in Overweight or Obese Patients with Atrial Fibrillation Scheduled for Catheter Ablation to Improve Treatment Outcomes

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with atrial fibrillation, which is a condition where the heart beats irregularly and often too fast. The treatment being studied is semaglutide, which is a medication that belongs to a group of medicines called GLP-1 receptor agonists. This medicine is given as an injection under the skin using a pre-filled pen. The study will include patients who are overweight or obese and who are scheduled to have a procedure called catheter ablation for the first time. Catheter ablation is a treatment where doctors use special equipment to correct the irregular heartbeat by targeting specific areas of the heart.

The purpose of this study is to find out if treatment with semaglutide can help patients stay free from irregular heart rhythms after having catheter ablation, compared to receiving standard care without this medication. The study will look at whether patients remain free from atrial fibrillation, atrial flutter, or atrial tachycardia (different types of irregular heart rhythms) lasting 30 seconds or longer during the 12 months following the ablation procedure. The study will not count any irregular heart rhythms that happen during the first 3 months after the procedure, as this is considered a normal recovery period.

During the study, patients will have their heart rhythm continuously monitored using a small device called an implantable loop recorder, which is placed under the skin to track the heart's activity over time. The treatment with semaglutide will be given for a period of up to 18 months, and the total study is expected to last several years. Women who could become pregnant will need to use effective birth control methods during the study and will have pregnancy tests to ensure they are not pregnant before starting.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessment
After providing written consent, your baseline information will be recorded. This includes your age, which must be at least 18 years old.
Your Body Mass Index (a measure of body weight relative to height) will be checked. It must be either 30 or higher, or 27 or higher if you have certain additional health conditions.
If you are a woman who could become pregnant, a pregnancy test will be performed. The test must be negative for you to participate. You will need to use reliable birth control methods throughout the study, such as hormonal contraception, an intrauterine device, or a barrier method combined with spermicide.
Step 2
Treatment initiation
You will be assigned to receive either semaglutide (a medication that acts on receptors in your body to help with weight management) or standard care without this medication.
If assigned to receive semaglutide, you will use Wegovy 0.5 mg FlexTouch, which is a pre-filled pen that delivers the medication as an injection under the skin.
The treatment will begin before your scheduled catheter ablation procedure. Catheter ablation is a procedure where a thin tube is inserted into your heart to treat irregular heart rhythm by creating small scars in the heart tissue, specifically using a technique called pulmonary vein isolation.
The exact dosage schedule, frequency of injections, and duration of treatment before the ablation procedure will be determined according to the study protocol.
Step 3
Catheter ablation procedure
You will undergo your first-time catheter ablation procedure for atrial fibrillation (an irregular and often rapid heart rhythm that can lead to poor blood flow).
The procedure aims to isolate the pulmonary veins, which are blood vessels that carry blood from the lungs to the heart and are often the source of the irregular electrical signals causing atrial fibrillation.
Step 4
Blanking period
The first three months after your ablation procedure is called the blanking period.
During this time, episodes of irregular heart rhythm may occur as part of the normal healing process and will not be counted in the main study results.
You will continue with your assigned treatment during this period.
Step 5
Continuous heart rhythm monitoring
An implantable loop recorder will be used to continuously monitor your heart rhythm. This is a small device placed under the skin that records your heart's electrical activity.
The device will detect any episodes of atrial fibrillation, atrial flutter (another type of irregular heart rhythm), or atrial tachycardia (abnormally fast heart rhythm originating in the upper chambers of the heart) that last 30 seconds or longer.
This monitoring will continue throughout the study period.
Step 6
Follow-up through 12 months post-ablation
You will be followed for 12 months after your ablation procedure.
The main goal is to determine whether you remain free from atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or longer during this time (excluding the initial three-month blanking period).
Your heart rhythm data will be collected continuously through the implantable loop recorder.
The duration of semaglutide treatment and follow-up assessments will occur according to the study schedule.

Who can join the trial?

6 criteria

You must provide written informed consent, which means you agree in writing to take part in the study before any procedures begin.
You must be 18 years of age or older.
You must be scheduled for your first-time catheter ablation for atrial fibrillation. Catheter ablation is a procedure where a thin tube is inserted into your heart to treat irregular heartbeats. Atrial fibrillation is a condition where your heart beats irregularly.
The ablation procedure must use a technique called pulmonary vein isolation, which is a specific method to treat the irregular heartbeat.
Your Body Mass Index must be 30 or higher, which indicates obesity, OR your Body Mass Index must be 27 or higher with at least one additional health condition listed in the study protocol. Body Mass Index is a number calculated from your height and weight that shows if you are overweight or obese.
If you are a woman who can become pregnant, you must have a negative pregnancy test before joining the study and agree to use highly effective birth control during the study period. Highly effective birth control includes methods such as hormonal pills or implants, an intrauterine device, or barrier methods like condoms combined with spermicide.

Who cannot join the trial?

8 criteria

Age restrictions: The study has specific age requirements that must be met to participate
Previous catheter ablation: You cannot participate if you have already had a catheter ablation procedure for atrial fibrillation (a type of irregular heartbeat) in the past, as this study is only for patients having their first ablation
Weight requirements: You must be overweight or obese to participate, meaning patients with normal weight cannot join this study
Not scheduled for ablation: You must be scheduled to have a catheter ablation (a procedure that uses thin tubes to treat irregular heartbeat) to be eligible for this study
Pregnancy or planning pregnancy: Women who are pregnant, breastfeeding, or planning to become pregnant during the study period typically cannot participate
Known allergies: You cannot participate if you have a known allergy to semaglutide (the study medication, which is a type of medicine that helps control blood sugar and weight) or any of its ingredients
Certain medical conditions: You may be excluded if you have other serious medical conditions that could interfere with the study or make the treatment unsafe for you
Current use of similar medications: You may not be able to participate if you are already taking GLP-1 receptor agonist medications (a class of drugs that help control blood sugar and weight)

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Karolinska University Hospital
Solna, Sweden

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Investigated drugs

Semaglutide is a medication that works by mimicking a natural hormone in your body called GLP-1. It helps control blood sugar levels and can also help with weight loss. In this trial, it is being tested to see if it can help improve the success of a heart procedure called catheter ablation in patients who have an irregular heartbeat condition called atrial fibrillation and are overweight or obese.

Semaglutide

What is already known about the treatment

Semaglutide – Semaglutide is a medication that belongs to a group of drugs called GLP-1 receptor agonists, which work by mimicking a natural hormone in the body that helps control blood sugar levels and reduces appetite. It is typically given as an injection under the skin once a week and is currently approved for treating type 2 diabetes and helping with weight loss in overweight or obese individuals. In this clinical trial, researchers are studying whether semaglutide can help patients with atrial fibrillation (an irregular heart rhythm) who are overweight or obese stay free from abnormal heart rhythms after a procedure called catheter ablation. The medication works at the molecular level by attaching to specific receptors on cells, which triggers a chain of events that lowers blood sugar, slows down stomach emptying, and signals the brain to reduce hunger.

Investigated diseases

Atrial Fibrillation
Atrial fibrillation is a heart rhythm disorder where the upper chambers of the heart beat irregularly and often rapidly. Instead of contracting in a coordinated way, the atria quiver or fibrillate, which prevents them from pumping blood effectively into the lower chambers. This irregular rhythm occurs because electrical signals in the heart become disorganized. The condition may come and go in episodes, or it may be persistent and continuous. When the heart beats irregularly, blood can pool in the atria and may form clots. Over time, atrial fibrillation can lead to various complications affecting the heart and overall circulation.
Atrial Flutter
Atrial flutter is a heart rhythm disorder similar to atrial fibrillation but with a more organized pattern. In this condition, the upper chambers of the heart beat too quickly but in a regular, rapid rhythm rather than chaotically. The electrical signals travel in a circular pattern around the atria, causing them to contract faster than normal. This rapid beating prevents the atria from filling and emptying properly between beats. Atrial flutter can occur in episodes that start and stop suddenly, or it may be ongoing. The condition often alternates with atrial fibrillation in some patients.
Atrial Tachycardia
Atrial tachycardia is a type of abnormal heart rhythm that originates in the upper chambers of the heart. The condition causes the heart to beat faster than normal, typically at a rate between 100 and 250 beats per minute. Unlike normal heart rhythm, the rapid beating starts from an abnormal electrical focus in the atria rather than from the heart's natural pacemaker. Episodes may begin suddenly and end just as quickly, or the rapid rhythm may be sustained. The fast heart rate reduces the time available for the heart chambers to fill with blood between beats. This condition can occur in people with or without other heart problems.