Active not recruitingOBSERVATIONAL

Outcome of Overweight AF Patients Following Ablation With a Potential Weight Loss Medication ( GOAL-AF )

This study is for overweight people with an irregular heartbeat called Atrial Fibrillation (AF) who are waiting for a procedure called ablation. AF causes symptoms like palpitations and breathlessness, and can increase stroke risk. While ablation helps, it works less well if you're overweight. Researchers want to see if using a weight-loss medication called Liraglutide before ablation can lead to better outcomes. They will study if accelerated weight loss helps the ablation work effectively, reduces repeat procedures, and improves the patient’s recovery and general health. This will help inform whether this approach should be used more widely in the future.

At a glance

Status

Active not recruiting

Sponsor

University Hospital Birmingham

Enrolment target

Start

17 Apr 2022

Estimated completion

01 Jun 2026

Atrial Fibrillation Recurrence Overweight and Obesity Liraglutide

What is this study about?

Many patients with an irregular heartbeat called Atrial Fibrillation (AF) experience symptoms like palpitations (feeling your heart race or flutter) and breathlessness. A procedure called ablation is often used to correct AF and help keep your heart rhythm regular. While ablation is effective, it sometimes doesn't work as well, or the AF can come back, especially if other health issues like high blood pressure, diabetes, or obesity are present.

Previous research has shown that losing weight and improving fitness can really help make ablation more successful. However, it can be hard to achieve these lifestyle changes quickly on your own. This study is exploring a new approach: using a medication called Liraglutide, which has been shown to help people lose weight, before having your ablation. The goal is to see if losing weight more rapidly with Liraglutide can improve the chances of the ablation being successful and reduce the risk of your AF coming back later.

The main purpose of this study is to find out if this idea is practical and safe. If it is, the information gained from this study could be used to plan a larger study in the future. Ultimately, the hope is to find better ways to help people with AF achieve longer-lasting benefits from their ablation procedure and improve their overall quality of life.

Key takeaways

This study investigates if weight loss before AF ablation improves results.
It uses a weight-loss medication called Liraglutide.
Participants must be overweight with AF and awaiting ablation.
The study aims to make ablations more successful and reduce AF recurrence.
Participation involves extra visits, tests, and self-administering injections.
You can stop participating at any time.

Who may be eligible?

This study is looking for around 30 patients who are already on the waiting list for an AF ablation procedure at Queen Elizabeth Hospital in Birmingham. To be considered, you need to be over 18 and under 80 years old, diagnosed with either occasional (paroxysmal) or ongoing (persistent) AF, and experiencing noticeable symptoms that haven't been well-controlled by other medications.

Crucially, you must also be classified as overweight or obese, with a Body Mass Index (BMI) of 30 kg/m² or higher. This study focuses specifically on the benefits of weight loss in this group of patients before their ablation. If you fit these general descriptions, you might be eligible to take part.

However, there are also some reasons why you might not be able to join. For example, if you can't have an MRI scan, are already taking other weight-loss medications (including other similar drugs like Liraglutide), have Type 1 diabetes, or Type 2 diabetes managed with certain medications (like DPP-IV inhibitors or insulin), you wouldn't be able to participate. Certain other serious health conditions like liver or kidney disease, severe heart failure, active cancer, or a history of thyroid cancer or pancreatitis would also prevent you from joining. The study also cannot include pregnant individuals or those with a fear of needles.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I over 18 but under 80 years old?
Do I have Atrial Fibrillation that causes symptoms?
Am I on the waiting list for an AF ablation at Queen Elizabeth Hospital Birmingham?
Is my Body Mass Index (BMI) 30 or higher (considered overweight or obese)?
Do I NOT have Type 1 diabetes or Type 2 diabetes on insulin/certain other drugs?
Do I NOT have other serious health conditions like severe liver/kidney disease, active cancer, or a history of thyroid cancer or pancreatitis?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be guided by a dedicated research team, including a research fellow and nurses. You'll have an initial visit where baseline information like your weight, height, and routine blood tests are taken. You'll also receive a special heart monitor (Kardia device) and fill out questionnaires about your well-being. A routine heart MRI will also be part of this initial assessment.

A key part of the study involves learning how to give yourself an injection of Liraglutide, the weight-loss medication. You'll be carefully trained on this. You'll also have an extra procedure called right atrial mapping, which is a 30-minute procedure done under light sedation through a vein in your leg. This is a day-case procedure, but you won't be able to drive for 48 hours afterward and should plan for 5-7 days off work. A recording of this procedure will be available to help you understand it before you decide to join.

After this initial visit, you will take the Liraglutide for 13 weeks. At the end of this period, you will have a second visit for a follow-up assessment. The total duration of active participation in the study, including the medication and follow-up, is expected to be around 13 weeks.

Potential risks and benefits

Participating in this study might offer you the potential benefit of losing weight more quickly before your ablation, which research suggests could lead to a more successful procedure and improve your overall health. You'll also receive close medical monitoring throughout. However, there are potential risks, including side effects from the Liraglutide medication (which will be fully explained) and the need for extra procedures and visits, such as the right atrial mapping, which carries its own small risks. You will be unable to drive for two days and need time off work for this procedure. It's important to remember that you are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Birmingham NHS Foundation Trust
Verified postcode
Birmingham, United Kingdom

Common questions

What is Atrial Fibrillation (AF)?

AF is a common condition where your heart beats irregularly, causing symptoms like palpitations, breathlessness, and tiredness.

What is an ablation procedure?

Ablation is a procedure that uses heat or cold to create small scars in your heart to block abnormal electrical signals and restore a normal heart rhythm.

What is Liraglutide?

Liraglutide is a medication that helps with weight loss. In this study, it's used to see if losing weight before ablation improves outcomes.

Will I have to pay for anything if I join?

No, all aspects of your participation in the study, including the medication and extra tests, will be covered by the study.

How long will I be in the study?

The active part of the study, including taking the medication and follow-up, is expected to last about 13 weeks.