NCT06715449 EMPA-ESUS. a Randomised Control Trial to Investigate the Impact of Empagliflozin on Left Atrial Function in Patients with Embolic Stroke of Undetermined Source

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 100 participants in total. It began in 2024-11-22 with a primary completion date of 2026-07.

Brief 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 Criteria

Inclusion Criteria: * Age over 18 years * Patient has had an embolic stroke of undetermined source, defined as: * Ischaemic stroke or transient ischaemic attack diagnosed clinically + supporting radiological features on CT or MRI imaging * No clinically significant extracranial or intracranial atherosclerosis found on neck imaging * No evidence of prevalent cardioembolic source of embolism - atrial dysrhythmia, cardiac thrombus, prosthetic valve, cardiac tumours, mitral stenosis, recent MI, LVEF\<35%, valvular vegetations, or infective endocarditis AND * No other specific stroke aetiology identified (pro-thrombotic states, arteritis, dissection, drug abuse) * Patient has been referred for an implantable loop recorder implant to investigate possible atrial dysrhythmia * Ability to give written, informed consent Exclusion Criteria: * Prevalent atrial fibrillation or atrial flutter * Subsequent demonstration of a cardio-emoblic source * Pre-existent indication for SGLT2i including heart failure with a reduced ejection fraction and Type 1 or Type 2 diabetes mellitus * Contraindication to the commencement of SGLT2i including a history of, or risk factors for diabetic ketoacidosis, such as restricted food intake or a history of alcohol abuse * Hypersensitivity to the active substance or to any of the excipients of empagliflozin * Presence of alternate implantable cardiac devices such as a pacemaker or defibrillator, that would make ILR utilisation redundant * Any condition that may confound the results or interfere with participation such as dementia * An unwillingness to participate

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