Actively Recruiting
EMPA-ESUS: A Randomized Trial Investigating Empagliflozin's Impact on Left Atrial Function in Patients with Embolic Stroke of Undetermined Source
Led by University of East Anglia · Updated on 2024-12-04
100
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
U
University of East Anglia
Lead Sponsor
A
Addenbrookes Hospital, Cambridge
Collaborating Sponsor
AI-Summary
What this Trial Is About
Atrial fibrillation (AF) is a common heart rhythm problem that greatly increases stroke risk. This research focuses on patients who have had an embolic stroke of undetermined source, many of whom later develop AF detected by implantable loop recorders. The study aims to see if empagliflozin, a Sodium Glucose Cotransporter 2 (SGLT2) inhibitor, can prevent changes in the left atrium of the heart that might lead to AF, using advanced imaging and continuous heart rhythm monitoring. Participants undergoing loop recorder insertion to detect AF after a stroke will be randomly assigned to either receive empagliflozin 10 mg daily alongside usual stroke care or to continue with usual care alone for six months. Baseline and six-month follow-up assessments will include echocardiograms, electrocardiograms, and measurements of body metrics. A subset of patients will also have advanced MRI scans to explore how empagliflozin might affect the heart's function. Throughout the trial, participants will be remotely monitored via their loop recorders to detect AF episodes. Researchers will measure changes in left atrial function, AF burden, time to first AF episode, and P-wave markers at six months. The study will also track any changes in left atrial volume and body measurements, with the goal of understanding if empagliflozin influences heart rhythm and structure in this high-risk group.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Clinical diagnosis of embolic stroke or transient ischemic attack with supporting CT or MRI imaging
- No significant extracranial or intracranial atherosclerosis on neck imaging
- No known sources of cardioembolic embolism such as atrial dysrhythmia, cardiac thrombus, prosthetic valve, cardiac tumors, mitral stenosis, recent myocardial infarction, severely reduced heart function, valvular vegetations, or infective endocarditis
- No other identified stroke causes such as pro-thrombotic states, arteritis, dissection, or drug abuse
- Referral for implantable loop recorder implantation to detect atrial dysrhythmia
- Ability to provide written informed consent
You will not qualify if you...
- Existing atrial fibrillation or atrial flutter
- Discovery of a cardioembolic source after initial assessment
- Pre-existing need for SGLT2 inhibitor treatment including heart failure with reduced ejection fraction or diabetes mellitus type 1 or 2
- Contraindications to SGLT2 inhibitors such as risk factors for diabetic ketoacidosis, restricted food intake, or history of alcohol abuse
- Allergy or hypersensitivity to empagliflozin or its components
- Presence of other implantable cardiac devices like pacemakers or defibrillators that interfere with loop recorder use
- Conditions that could affect study results or participation like dementia
- Unwillingness to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive empagliflozin 10mg once daily in addition to usual stroke care or continue with usual stroke care alone, with assessments at baseline and 6 months including echocardiography, electrocardiography, and anthropometric measurements.
2 visits (baseline and 6 months, in-person)
Trial Site Locations
Total: 1 location
1
Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
Research Team
V
Vassilios S Vassiliou, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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