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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

NCT06715449 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-04

No results posted yet for this study

Summary

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

  • Embolic Stroke of Undetermined Source
  • Atrial Fibrillation New Onset

Interventions

DRUG

Empagliflozin 10 MG

Participants allocated in the Intervention Group will be taking empagliflozin 10mg once a day in addition to their usual stroke care.

Sponsors & Collaborators

  • Addenbrookes Hospital, Cambridge

    collaborator UNKNOWN

  • University of East Anglia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2026-07-31
Completion
2029-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06715449 on ClinicalTrials.gov