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

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllUniversity of East Anglia
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In plain words

What the trial is, and whether it could suit you

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 fo

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Empagliflozin 10 MG
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Where

1 site
Addenbrookes Hospital
Cambridge, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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