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.
Age over 18 years
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
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
Parallel
Empagliflozin 10 MG
DrugParticipants allocated in the Intervention Group will be taking empagliflozin 10mg once a day in addition to their usual stroke care.
Change in left atrial reservoir strain
The left atrial reservoir strain (LArs) (expressed in %) will be assessed from the echocardiogram at baseline and at 6 months follow-up
Difference in ILR-detected AF burden
AF will be detected via the implantable loop recorder
Difference in time to first AF episode
Time to first AF episode will be measured from time of ILR implantation to time of first AF detection
Change in P-wave terminal force
P-wave terminal force will be measured using the V1 lead on 12-lead ECG
Change in P-wave axis
P-wave axis will be measured using a 12-lead ECG
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University of East Anglia
Lead sponsor
Addenbrookes Hospital, Cambridge
Collaborator
