Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
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

Led by University of East Anglia · Updated on 2024-12-04

100

Participants Needed

1

Research Sites

222 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 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.

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Patient has had an embolic stroke of undetermined source confirmed by clinical diagnosis and imaging
  • No significant extracranial or intracranial atherosclerosis found on neck imaging
  • No evidence of cardioembolic source including atrial dysrhythmia, cardiac thrombus, prosthetic valve, cardiac tumors, mitral stenosis, recent myocardial infarction, low ejection fraction, valvular vegetations, or infective endocarditis
  • No other specific stroke causes identified such as pro-thrombotic states, arteritis, dissection, or drug abuse
  • Patient has been referred for implantable loop recorder insertion to detect atrial dysrhythmia
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Existing atrial fibrillation or atrial flutter
  • Later detection of cardioembolic source
  • Pre-existing need for SGLT2 inhibitors including heart failure with reduced ejection fraction or diabetes mellitus
  • Contraindications to SGLT2 inhibitors such as risk of diabetic ketoacidosis, restricted food intake, or alcohol abuse history
  • Allergy to empagliflozin or its ingredients
  • Presence of other implantable cardiac devices like pacemaker or defibrillator making ILR use redundant
  • Any condition that could interfere with study participation or confound results such as dementia
  • Unwillingness to participate in the trial

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Addenbrookes Hospital

Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Actively Recruiting

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Research Team

V

Vassilios S Vassiliou, PhD

CONTACT

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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