RecruitingPhase 2Phase 3NCT06715449

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


Sponsor

University of East Anglia

Enrollment

100 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Atrial fibrillation (AF) is the most common heart rhythm problem in the adult population. There is a five-fold increase in stroke risk in patients with AF. Whilst there has been considerable advances in AF management including improvement in ablation therapy, preventing AF remains an unmet need. One promising avenue is a group of medications called Sodium Glucose Cotransporter 2 (SGLT2) inhibitors, which has been studied in people with diabetes, kidney disease and weak heart muscle. These medicines were consistently found to lower the risk of developing AF. This can be promising for patients who have suffered a stroke for unclear reasons, where a significant proportion are subsequently found to have short periods of AF. Often prior to AF development, patients may have changes in the structure or function of the top chambers of their heart (the atria). This may provide a useful marker for us to understand whether SGLT2i impacts AF risk. Aim of research study: The aim of this study is to investigate whether the use of the drug empagliflozin, an SGLT2 inhibitor, prevents changes in the left atrium associated with future AF development. Using advanced imaging techniques and continuous rhyth monitoring we intend to study the effect of SGLT2 inhibitors on left atrial function and arrhythmia occurence. Study design: Patients who are undergoing an implantable loop recorder insertion, to detect AF following a stroke, will be invited for participation. Eligible consenting patients will have a baseline assessment with echocardiography, electrocardiogram and anthropometric measures. They will then be randomised to receive either the SGLT2i alongside usual stroke care for 6 months, or usual stroke care alone. All patients will be monitored remotely via their loop recorder, and will undergo repeat electrocardiogpahic, echocardiographic and anthropometric assessment at 6 months. This way, we aim to investigate whether the SGLT2 inhibitor causes changes in atrial parameters that may be associated with future AF development.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (EMPA-ESUS) is testing whether a diabetes drug called empagliflozin (an SGLT2 inhibitor) can improve heart function and reduce the risk of future stroke in people who had a stroke of unknown cause (called embolic stroke of undetermined source, or ESUS). These patients are being monitored with an implanted heart monitor to check for irregular heart rhythms. **You may be eligible if...** - You are over 18 years old - You had an ischemic stroke or mini-stroke (TIA) with no identified cause - No significant blockages, blood clots, or heart rhythm problems were found to explain your stroke - You are already scheduled to receive an implanted heart monitor (loop recorder) **You may NOT be eligible if...** - You already have atrial fibrillation (irregular heartbeat) - A cause for the stroke has since been found - You already have diabetes or heart failure (conditions already requiring SGLT2 inhibitors) - You have risk factors for diabetic ketoacidosis (e.g., restricted food intake, alcohol abuse) - You have a pacemaker or defibrillator that would make the loop recorder unnecessary - You are allergic to empagliflozin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 10 MG

Participants allocated in the Intervention Group will be taking empagliflozin 10mg once a day in addition to their usual stroke care.


Locations(1)

Addenbrookes Hospital

Cambridge, Cambridgeshire, United Kingdom

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NCT06715449


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