EMPA-ESUS.
Research type
Research Study
Full title
EMPA-ESUS. A randomised control trial to investigate the impact of Empagliflozin on left atrial function in patients with embolic stroke of undetermined source
IRAS ID
318615
Contact name
Vassilios Vassiliou
Contact email
Sponsor organisation
The University of East Anglia
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 5 days
Research summary
Atrial fibrillation (AF) is the most common arrhythmia in the adult population. There is a five-fold increase in stroke risk in patients with AF. Whilst there has been considerable development in AF management including improvement in ablation therapy, preventing AF remains an unmet need.
This is particularly important in populations at risk of AF development, such as individuals who suffer an embolic stroke of undetermined source (ESUS). ESUS represents approximately 17% of patients with ischaemic stroke, in whom an aetiology is not identified. We have demonstrated that more than 40% of ESUS patients develop AF if monitored with an implantable loop recorder (ILR).
It has been suggested that sodium glucose co-transporter 2 inhibitors (SGLT2i) can cause a significant reduction in AF, as high as 48% based on analysis of previous studies. If SGLT2i are shown to reduce SCAF in ESUS, it will prompt further research into other high risk patient groups, and whether they lead to a reduction in stroke recurrence rate.
The aim of this project is to assess whether treatment with Empagliflozin impacts left atrial strain, which is considered an important predictor for future AF.
We propose a pragmatic randomised control trial, for which a total of 100 patients with ESUS undergoing ILR implantation will be recruited. Patients will be randomised either to receive a 6-months of empaglaflozin alongside their usual stroke care, or usual stroke care alone. Data from the ILR will be reviewed on a regular basis, as well as specifically if there are any algorithm detected alerts or patient episodes. Patients will undergo ECG and echocardiogram at baseline as part of usual care, and these will be repeated at the end of the study period.
The primary outcome will be the change in left atrial strain from baseline to end of therapy.
REC name
South East Scotland REC 01
REC reference
24/SS/0040
Date of REC Opinion
17 Jun 2024
REC opinion
Further Information Favourable Opinion