RecruitingPHASE2, PHASE3INTERVENTIONAL

EMPA-ESUS. a Randomised Control Trial to Investigate the Impact of Empagliflozin on Left Atrial Function in Patients with Embolic Stroke of Undetermined Source

This study, called EMPA-ESUS, looks into whether a medicine called empagliflozin can help prevent an irregular heart rhythm called atrial fibrillation (AF) in people who have recently had a stroke where the cause wasn't clear. AF significantly increases stroke risk, and while treatments exist, preventing it is a big challenge. This research will use advanced heart scans and continuous heart monitoring to see if empagliflozin, a drug already used for diabetes, kidney disease, and heart failure, can protect the heart's upper chambers from changes that lead to AF. Participants will either receive the drug or standard stroke care, with close monitoring over six months through an implanted heart recorder.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

University of East Anglia

Enrolment target

100

Start

22 Nov 2024

Estimated completion

01 Mar 2029

Embolic Stroke of Undetermined Source Atrial Fibrillation New Onset

What is this study about?

This study is focused on a very common heart rhythm problem called atrial fibrillation, or AF. Many people who have a stroke where the doctors can't find a clear reason, might actually have short periods of AF that weren't detected at first. Discovering AF after a stroke makes it more likely for another stroke to happen. While treatments for AF exist, stopping it from developing in the first place is a key goal that could prevent future strokes and avoid the need for blood-thinning medicines, which carry their own risks like bleeding.

Researchers are particularly interested in a group of medicines called SGLT2 inhibitors, such as empagliflozin. These drugs have been used for conditions like diabetes and heart failure, and doctors have noticed they might also reduce the chance of developing AF. This study aims to find out if empagliflozin can help prevent changes in the upper chambers of the heart (called the atria) that often come before AF develops. These changes can be subtle and might be responsible for the initial stroke that didn't have a clear cause.

By carefully looking at the heart's function using special scans and continuously monitoring heart rhythm, the study hopes to understand if empagliflozin can protect the heart and reduce the risk of AF in people who are already at a higher risk. This could potentially lead to new ways of preventing AF and, in turn, preventing future strokes.

Key takeaways

This study evaluates empagliflozin for preventing atrial fibrillation after certain strokes.
It aims to understand if the drug can protect heart function and reduce future stroke risk.
Participation involves taking the drug or standard care for six months, with continuous heart monitoring.
You'll have heart scans and ECGs at the start and end of the six months.
The study helps determine if empagliflozin has a role beyond its current uses.

Who may be eligible?

To be considered for this study, you must be over 18 years old and have recently experienced a type of stroke called an "embolic stroke of undetermined source" (ESUS). This means doctors found no obvious cause for your stroke after checking for things like blockage in major blood vessels or other heart conditions. A key requirement is that you must also be scheduled to have a small heart monitor (called an implantable loop recorder) fitted to keep an eye on your heart rhythm.

You would not be able to join if you already have atrial fibrillation or another clear cause for your stroke has been found. Also, if you already take empagliflozin for another condition like diabetes or severe heart failure, or if you have certain health issues that make taking empagliflozin unsafe, you wouldn't be eligible. The study also cannot include you if you already have other implanted heart devices that would make the loop recorder unnecessary, or if you have a condition like dementia that might make participating difficult.

Quick self-check

Are you over 18 years old?
Have you had a stroke where doctors couldn't find a clear cause?
Are you scheduled to have a heart monitor (implantable loop recorder) fitted?
Do you currently have atrial fibrillation or another clear cause for your stroke?
Are you already taking empagliflozin for diabetes, heart failure, or kidney disease?
Do you have any other conditions that might make taking empagliflozin unsafe?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, after giving your consent, you will have an initial check-up. This will involve an ultrasound scan of your heart (echocardiogram), an electrical recording of your heart (ECG), and some basic measurements like your weight and height. You will then be randomly assigned, like flipping a coin, to either receive the study drug, empagliflozin, along with your usual stroke care, or just your usual stroke care alone. You won't know which group you are in, and neither will your doctors.

The study drug or regular care will continue for six months. During this time, your heart rhythm will be continuously monitored by the implantable loop recorder that you would have had fitted for your stroke care. After six months, you will have another set of assessments, including repeat heart scans, an ECG, and your measurements, to see if there have been any changes. The total duration of active participation in the study is six months, but the follow-up period may extend depending on the continuous monitoring.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by helping doctors understand whether empagliflozin can prevent atrial fibrillation, which might in turn reduce the risk of future strokes. However, there are also potential risks associated with taking any medication, and empagliflozin can have side effects, which your doctor will discuss with you. These could include urinary tract infections or low blood sugar, especially if you have diabetes. There's also the chance that the study drug might not have any benefit for you personally. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Addenbrookes Hospital
Cambridge, United Kingdom· Recruiting

Common questions

What is 'Embolic Stroke of Undetermined Source'?

This is a type of stroke where doctors have looked for common causes like blocked arteries or heart problems, but haven't found a clear reason for why the stroke happened.

What is empagliflozin?

Empagliflozin is a medicine typically used to treat type 2 diabetes, heart failure, and kidney disease. It helps the body remove sugar through urine.

What is atrial fibrillation (AF)?

AF is an irregular and often very fast heart rhythm. It can increase the risk of stroke and other heart-related problems.

Will I know if I'm getting the study drug or not?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you are receiving empagliflozin or just standard care. This helps ensure the results are unbiased.

What is an implantable loop recorder?

It's a small device placed under the skin, usually in the chest, that continuously monitors and records your heart's electrical activity (rhythm) to detect any irregularities.

How to find out more

Vassilios S Vassiliou, PhD

V.Vassiliou@uea.ac.uk 01603592534 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.